Rossum et al v. I-Flow Corporation et al

Filing 93

ORDER denying 77 Motion to Dismiss/General (Written Opinion). Signed by Judge Joan N. Ericksen on July 31, 2011. (Attachments: # 1 exhibit 1, # 2 exhibit 2) (slf)

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510(k) Clearances > January 2007 510(k) Clearances 1 of 31 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... Home > Medical Devices > Products and Medical Procedures > Device Approvals and Clearances Medical Devices January 2007 510(k) Clearances SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-JAN-2007 THROUGH 31-JAN-2007 DEVICE: A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC. ATTN: JERRY WANG 1555 MCCANDLESS DR. MILPITAS, CA 95035 510(k) NO: K062027 1(SPECIAL) PHONE NO : 408-518-5113 SE DECISION MADE: 19-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCIN UNI-KNEE SYSTEM ACCIN CORPORATION ATTN: MICHAEL KVITNITSKY 1033 US HIGHWAY 46 EAST SUITE A204 CLIFTON, NJ 07013 510(k) NO: K063782 2(SPECIAL) PHONE NO : 973-777-8832 SE DECISION MADE: 19-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T AESCULAP, INC. ATTN: MATTHEW M HULL 3773 CORPORATE PKWY. CENTER VALLEY, PA 18034 510(k) NO: K062009 3(TRADITIONAL) PHONE NO : 610-984-9072 SE DECISION MADE: 17-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 AGAMATRIX ATTN: CONNIE HERTEL 10 MAOR PARKWAY SALEM, NH 03079 510(k) NO: K063409 4(TRADITIONAL) PHONE NO : 603-328-6051 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIANCE CI PROCESS INDICATOR ALBERT BROWNE LTD. ATTN: CYNTHIA J.M. NOLTE 49 PLAIN STREET NORTH ATTLEBORO, MA 02760 510(k) NO: K063285 5(TRADITIONAL) PHONE NO : 919-859-4207 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMOGARD THERMAL REGULATION SYSTEM ALSIUS CORP. ATTN: KENNETH A COLLINS 15770 LAGUNA CANYON, SUITE 150 IRVINE, CA 92618 510(k) NO: K063829 6(SPECIAL) PHONE NO : 949-453-0150 SE DECISION MADE: 22-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX ALVEOLUS, INC. ATTN: DONALD CANAL 9013 PERIMETER WOODS DRIVE SUITE A CHARLOTTE, NC 28216 510(k) NO: K062511 7(TRADITIONAL) PHONE NO : 704-926-4850 SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALEXIS WOUND RETRACTOR APPLIED MEDICAL RESOURCES ATTN: CHERYL BLAKE 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA, CA 92688 510(k) NO: K062907 8(TRADITIONAL) PHONE NO : 949-713-8000 SE DECISION MADE: 09-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 2 of 31 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... DEVICE: AR1000 ULTRASONIC WOUND THERAPY SYSTEM AROBELLA MEDICAL, LLC ATTN: ALLISON SCOTT 11460 N. MERIDIAN STREET SUITE 150 CARMEL, IN 46032 510(k) NO: K062544 9(TRADITIONAL) PHONE NO : 317-569-9500 SE DECISION MADE: 03-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS ARTHREX, INC. ATTN: NANCY HOFT 1370 CREEKSIDE BLVD. NAPLES, FL 34108-1945 510(k) NO: K063058 10(TRADITIONAL) PHONE NO : 239-643-5553 SE DECISION MADE: 03-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY ARTHROSURFACE, INC. ATTN: DAWN J WILSON 28 FORGE PARKWAY FRANKLIN, MA 02038 510(k) NO: K063370 11(TRADITIONAL) PHONE NO : 508-520-3003 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAHI PTCA GUIDE WIRE, FIELDER FC ASAHI INTECC CO., LTD. ATTN: YOSHI TERAI 1301 DOVE STREET SUITE 350 NEWPORT BEACH, CA 92660 510(k) NO: K063819 12(SPECIAL) PHONE NO : 949-756-8252 SE DECISION MADE: 26-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED TROCARS ASCENT HEALTHCARE SOLUTIONS ATTN: ELIZABETH RENKIN 10232 SOUTH 51ST ST. PHOENIX, AZ 85044 510(k) NO: K062497 13(TRADITIONAL) PHONE NO : 480-763-5394 SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRICURE ABLATION SYSTEM ATRICURE, INC. ATTN: ELSA C ABRUZZO 6033 SCHUMACHER PARK DR. WEST CHESTER, OH 45069 510(k) NO: K063630 14(TRADITIONAL) PHONE NO : 513-755-4130 SE DECISION MADE: 26-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES AXON SYSTEMS, ATTN: HOWARD 400-2200 OSER HAUPPAUGE, NY INC. BAILIN AVE. 11788 510(k) NO: K062996 15(TRADITIONAL) PHONE NO : 631-436-5112 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AYCAN WORKSTATION OSIRIX AYCAN DIGITALSYSTEME GMBH ATTN: CARL ALLETTO 1600 MANCHESTER WAY CORINTH, TX 76210 510(k) NO: K063470 16(TRADITIONAL) PHONE NO : 940-300-8601 SE DECISION MADE: 05-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM B&W TEK, INC. ATTN: SEAN WANG 19 SHEA WAY, SUITE 301 NEWARK, DE 19713 510(k) NO: K062363 17(TRADITIONAL) PHONE NO : 302-368-7824 SE DECISION MADE: 17-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL) B. BRAUN MEDICAL, INC. ATTN: PAUL O'CONNELL 824 TWELFTH AVE. BETHLEHEM, PA 18018 510(k) NO: K063217 18(TRADITIONAL) PHONE NO : 847-274-0097 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 3 of 31 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... DEVICE: IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K BAXTER HEALTHCARE CORP. ATTN: JOHN MANARIK 1620 WAUKEGAN ROAD MCGAW PARK, IL 60085-6730 510(k) NO: K052973 19(TRADITIONAL) PHONE NO : 847-473-6294 SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, BAYLIS MEDICAL CO., INC. 510(k) NO: K062937 20(TRADITIONAL) ATTN: MEGHAL KHAKHAR PHONE NO : 905 602 4875 2580 MATHESON BLVD. E SE DECISION MADE: 08-JAN-07 MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-6 BECTON DICKINSON & CO. ATTN: VICKI KENNEDY WHITLEY 7 LOVETON CIR. SPARKS, MD 21152 510(k) NO: K063573 21(TRADITIONAL) PHONE NO : 410-316-4161 SE DECISION MADE: 11-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.12 BECTON, DICKINSON & CO. ATTN: VICKI K WHITLEY 7 LOVETON CIR. SPARKS, MD 21152-0999 510(k) NO: K063300 22(TRADITIONAL) PHONE NO : 410-316-4161 SE DECISION MADE: 29-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LANDLEX, MODEL S403X BESTEAM TECHNOLOGY INC. ATTN: JUNNATA CHANG 14F-2 NO. 1 LANE 25 ZHUANGJING RD. BANQIAO, CHINA (TAIWAN) 220 510(k) NO: K063196 23(TRADITIONAL) PHONE NO : 886 4 22465396 SE DECISION MADE: 23-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHARPS CONTAINER, MODEL 039-413 BIODEX MEDICAL SYSTEMS, INC. ATTN: CLYDE SCHLEIN 20 RAMSAY RD. SHIRLEY, NY 11967 510(k) NO: K063666 24(TRADITIONAL) PHONE NO : 631-924-9000 SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND A BIOKIT S.A. ATTN: JOAN GUIXER CAN MALE S/N LLISSA D'AMUNT BARCELONA, SPAIN 08186 510(k) NO: K060818 25(TRADITIONAL) PHONE NO : 349 386 090 SE DECISION MADE: 23-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZLASE BIOLASE TECHNOLOGY, INC. ATTN: IOANA M RIZOIU 4 CROMWELL IRVINE, CA 92618 510(k) NO: K061898 26(TRADITIONAL) PHONE NO : 949-361-1200 SE DECISION MADE: 26-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. ATTN: JOLYN TENLLADO 595 ANGLUM RD. HAZELWOOD, MO 63042 510(k) NO: K063597 27(TRADITIONAL) PHONE NO : 314-731-8386 SE DECISION MADE: 19-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. ATTN: JOLYN TENLLADO 595 ANGLUM RD. HAZELWOOD, MO 63042 510(k) NO: K063623 28(TRADITIONAL) PHONE NO : 314-731-8386 SE DECISION MADE: 11-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 4 of 31 BIOMET MANUFACTURING CORP. ATTN: JING XIE PO BOX 587 WARSAW, IN 46581-0587 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... 510(k) NO: K062998 29(TRADITIONAL) PHONE NO : 574-267-6639 SE DECISION MADE: 19-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROPLASTY TIBIAL TRAYS BIOMET MANUFACTURING CORP. ATTN: BECKY EARL PO BOX 587 WARSAW, IN 46581-0587 510(k) NO: K063732 30(TRADITIONAL) PHONE NO : 574-267-6639 SE DECISION MADE: 18-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIAGE PROTEIN C TEST BIOSITE INCORPORATED ATTN: FIL V BUENVIAJE 9975 SUMMERS RIDGE RD SAN DIEGO, CA 92121 510(k) NO: K062530 31(TRADITIONAL) PHONE NO : 858-805-2722 SE DECISION MADE: 29-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/M BIOTOP TECHNOLOGY CO., LTD. ATTN: LYDIA LEE CHUNG-HSIAO E. ROAD, SEC. 2 12F-2, NO. 130 TAIPEI, CHINA (TAIWAN) 100 510(k) NO: K062318 32(TRADITIONAL) PHONE NO : 886 2 23957606 SE DECISION MADE: 03-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUET SYSTEM BIOVIEW LTD. ATTN: DORIT WINITZ 7 JABOTINSKY ST. RAMAT GAN, ISRAEL 52520 510(k) NO: K061602 33(TRADITIONAL) PHONE NO : 972 361 232981 SE DECISION MADE: 23-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE BOND SE BISCO, INC. ATTN: BENJAMIN LICHTENWALNER 1100 WEST IRVING PARK RD. SCHAUMBURG, IL 60193 510(k) NO: K063780 34(SPECIAL) PHONE NO : 847-534-6146 SE DECISION MADE: 19-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BONART ART-L3 LED CURING LIGHT BONART CO. LTD. ATTN: ERIC L ONG 398 S. LEMON CREEK DR. STE. L WALNUT, CA 91789 510(k) NO: K062289 35(TRADITIONAL) PHONE NO : 909-594-8066 SE DECISION MADE: 03-JAN-07 510(k) STATEMENT DEVICE: MODIFICATION TO VECTORVISION TRAUMA BRAINLAB, AG ATTN: RAINER BIRKENBACH KAPELLENSTR. 12 FELDKIRCHEN, GERMANY 85622 510(k) NO: K062358 36(SPECIAL) PHONE NO : 498 999 15680 SE DECISION MADE: 17-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BREAS ISLEEP 20I BREAS MEDICAL AB ATTN: KARL-JOHAN HOLM FORETAGSVAGEN 1 MOLNLYCKE, SWEDEN 435 33 510(k) NO: K063476 37(SPECIAL) PHONE NO : 46 318 68800 SE DECISION MADE: 22-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLASS LOSS OF RESISTANCE SYRINGE BUSSE HOSPITAL DISPOSABLES, INC. ATTN: MUHAMAD ANSARI 75 ARKAY DR. HAUPPAUGE, NY 11788 510(k) NO: K063018 38(TRADITIONAL) PHONE NO : 631-435-4711 SE DECISION MADE: 22-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER C.R. BARD, INC. ATTN: MICHAELA RIVKOWICH 510(k) NO: K063377 39(TRADITIONAL) PHONE NO : 801-595-0700 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 5 of 31 5425 WEST AMELIA EARHART DR. SALT LAKE CITY, UT 84116 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER C.R. BARD, INC. ATTN: TERRI MORRIS 13183 HARLAND DRIVE COVINGTON, GA 30014-6421 510(k) NO: K063632 40(SPECIAL) PHONE NO : 678-342-4922 SE DECISION MADE: 05-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CF-1 CANON, INC. ATTN: SHEILA DRISCOLL ONE CANON PLAZA LAKE SUCCESS, NY 11042-1198 510(k) NO: K063717 41(TRADITIONAL) PHONE NO : 516-328-5602 SE DECISION MADE: 23-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM CARDICA, INC. ATTN: TIFFINI LALUDE 900 SAGINAW DR. REDWOOD CITY, CA 94063 510(k) NO: K063644 42(SPECIAL) PHONE NO : 650-331-7153 SE DECISION MADE: 11-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIRRUS HD-OCT, MODEL 4000 CARL ZEISS MEDITEC INC ATTN: JUDITH A BRIMACOMBE 5160 HACIENDA DR. DUBLIN, CA 94568 510(k) NO: K063378 43(TRADITIONAL) PHONE NO : 925-557-4616 SE DECISION MADE: 26-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT CATACHEM, INC. ATTN: LUIS P LEON 955 CONNECTICUT AVENUE SUITE 4106 BRIDGEPORT, CT 06607 510(k) NO: K062503 44(TRADITIONAL) PHONE NO : 203-335-9277 SE DECISION MADE: 19-JAN-07 510(k) STATEMENT DEVICE: OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTI CEREMED INC. ATTN: TADEUSZ WELLISZ M.D. 3643 LENAWEE AVE. LOS ANGELES, CA 90016 510(k) NO: K070093 45(SPECIAL) PHONE NO : 310-815-2125 SE DECISION MADE: 24-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED MERCI RETRIEVER, MODEL 90050 CONCENTRIC MEDICAL, INC. ATTN: KIRSTEN VALLEY 1380 SHOREBIRD WAY MOUNTAIN VIEW, CA 94043 510(k) NO: K062046 46(TRADITIONAL) PHONE NO : 650-938-2100 SE DECISION MADE: 19-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6 CONCENTRIC MEDICAL, INC. ATTN: KIRSTEN VALLEY 1380 SHOREBIRD WAY MOUNTAIN VIEW, CA 94043 510(k) NO: K063774 47(SPECIAL) PHONE NO : 650-938-2100 SE DECISION MADE: 24-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED ABC DISSECTING BLADE ELECTRODE, MODEL 139330; BLUNT NEEDL CONMED CORPORATION ATTN: SHAWN RIEDEL 14603 E. FREMONT AVE. CENTENNIAL, CO 80112 510(k) NO: K062082 48(TRADITIONAL) PHONE NO : 303-269-8224 SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED LINVATEC 24K IRRIGATION SYSTEM CONMED LINVATEC ATTN: SUE F DAUTERMAN 11311 CONCEPT BOULEVARD LARGO, FL 33773-4908 510(k) NO: K063326 49(TRADITIONAL) PHONE NO : 727-399-5321 SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 6 of 31 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... DEVICE: SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR CUSTOM ULTRASONICS ATTN: LAWRENCE F MUSCARELLA 144 RAILROAD DR. IVYLAND, PA 18974 510(k) NO: K061430 50(TRADITIONAL) PHONE NO : 215-364-1477 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: YAG MIR II LASER CYNOSURE, INC. ATTN: GEORGE CHO 5 CARLISLE ROAD WESTFORD, MA 01886 510(k) NO: K070063 51(SPECIAL) PHONE NO : 978-256-4200 SE DECISION MADE: 30-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT CYTORI THERAPEUTICS, INC. ATTN: KENNETH K KLEINHENZ 3020 CALLAN ROAD SAN DIEGO, CA 92121-1109 510(k) NO: K063235 52(TRADITIONAL) PHONE NO : 858-458-0900 SE DECISION MADE: 24-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3 SERIES PHOTOTHERAPY CABINET DAAVLIN CO. ATTN: TARA MANSUR 205 WEST BEMENT ST. P.O. BOX 626 BRYAN, OH 43506 510(k) NO: K063621 53(TRADITIONAL) PHONE NO : 419-636-6304 SE DECISION MADE: 17-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRAT DADE BEHRING, INC. ATTN: KATHLEEN DRAY-LYONS P.O. BOX 6101 NEWARK,, DE 19714 510(k) NO: K063272 54(TRADITIONAL) PHONE NO : 781-826-4551 SE DECISION MADE: 26-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR DADE BEHRING, INC. ATTN: KATHLEEN DRAY-LYONS GLASGOW SITE, PO BOX 6101 NEWARK, DE 19714-6101 510(k) NO: K063322 55(TRADITIONAL) PHONE NO : 781-826-4551 SE DECISION MADE: 24-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATO DADE BEHRING, INC. ATTN: KATHLEEN A DRAY-LYONS P.O. BOX 6101 NEWARK,, DE 19714 510(k) NO: K063351 56(TRADITIONAL) PHONE NO : 781-826-4551 SE DECISION MADE: 22-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEI DADE BEHRING, INC. ATTN: HELEN M LEE P.O. BOX 6101 NEWARK,, DE 19714 510(k) NO: K063508 57(TRADITIONAL) PHONE NO : 302-631-8706 SE DECISION MADE: 23-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBR DADE BEHRING, INC. ATTN: KATHLEEN DRAY-LYONS P.O. BOX 6101 NEWARK,, DE 19714 510(k) NO: K063610 58(TRADITIONAL) PHONE NO : 781-826-4551 SE DECISION MADE: 11-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHE DATASCOPE CORP. ATTN: NANCY COHEN 15 LAW DR. FAIRFIELD, NJ 07004-0011 510(k) NO: K063525 59(SPECIAL) PHONE NO : 973-244-6104 SE DECISION MADE: 05-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHASE 3, MODEL DT-1 DATREND SYSTEMS, INC. 510(k) NO: K062099 60(TRADITIONAL) 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 7 of 31 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... ATTN: RON EVANS PHONE NO : 604-291-7747 3531 JACOMBS RD., UNIT 1 SE DECISION MADE: 25-JAN-07 RICHMOND, BRITISH COLUMBIA, CANADA510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENTINEL DEL MAR REYNOLDS MEDICAL, LTD. ATTN: GEORGE MYERS 377 ROUTE 17 S HASBROUCK HEIGHTS, NJ 07604 510(k) NO: K062397 61(SPECIAL) PHONE NO : 201-727-1703 SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEN TEK NIGHTGUARD DENTEK ORAL CARE, INC. ATTN: JEFFREY SHAPIRO 555 THIRTEENTH STREET, NW WASHINGTON, DC 20004 510(k) NO: K063483 62(TRADITIONAL) PHONE NO : 202-637-5775 SE DECISION MADE: 23-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARRARA VOLUMIA DENTSPLY INTL. ATTN: HELEN LEWIS 221 WEST PHILADELPHIA STREET SUITE 60 YORK, PA 17404 510(k) NO: K070019 63(SPECIAL) PHONE NO : 717-845-7511 SE DECISION MADE: 26-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY PEAK FX HIP PLATE DEPUY ORTHOPAEDICS, INC. ATTN: RHONDA MYER 700 ORTHOPAEDIC DRIVE WARSAW, IN 46582 510(k) NO: K063509 64(TRADITIONAL) PHONE NO : 574-371-4927 SE DECISION MADE: 04-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. ATTN: CHRISTOPHER 325 PARAMOUNT DR. RAYNHAM, MA 02767 KLACZYK 510(k) NO: K063741 65(SPECIAL) PHONE NO : 508-828-2852 SE DECISION MADE: 17-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 DIAGNOSTIC CHEMICALS LTD. ATTN: DEBBIE M MURRAY 16 MCCARVILLE ST. CHARLOTTETOWN, P.E.I., CANADA C1E 510(k) NO: K063208 66(TRADITIONAL) PHONE NO : 902 566 1396 SE DECISION MADE: 19-JAN-07 510(k) STATEMENT DEVICE: DIOMED DELTA 25 DIOMED, LTD. ATTN: TIM PHIPPS CAMBRIDGE RESEARCH PARK BUILDING 2000 CAMBRIDGE, CAMBRIDGESHIRE, UNITED 510(k) NO: K063828 67(SPECIAL) PHONE NO : 44 122 3729300 SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA KINGDOM CB5 9TE DEVICE: RELIEF ACP ORAL CARE GEL DISCUS DENTAL INC. ATTN: STEVEN L ZIEMBA 8550 HIGUERA ST. CULVER CITY, CA 90232 510(k) NO: K062176 68(TRADITIONAL) PHONE NO : 310-845-8345 SE DECISION MADE: 10-JAN-07 510(k) STATEMENT DEVICE: EIGEN DSA 2000 EIGEN ATTN: NATALIE J KENNEL 13721 VIA TRES VISTA SAN DIEGO, CA 92129 510(k) NO: K063846 69(SPECIAL) PHONE NO : 858-705-0350 SE DECISION MADE: 26-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEODESIC EEG SYSTEM 300 ELECTRICAL GEODESICS, INCORPORATED510(k) NO: K063797 70(SPECIAL) ATTN: LINDA J BOVARD PHONE NO : 541-345-5431 29611 SIMMONS ROAD SE DECISION MADE: 25-JAN-07 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 8 of 31 EUGENE, OR 97405 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUMAPEN LUXURA HD ELI LILLY AND CO. ATTN: LEEANN CHAMBERS LILLY CORPORATE CENTER INDIANAPOLIS, IN 46285 510(k) NO: K063151 71(TRADITIONAL) PHONE NO : 317-277-1813 SE DECISION MADE: 09-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELECT TENS, MODEL 4600S EMPI ATTN: CARL BEAURLINE 599 CARDIGAN RD. ST. PAUL, MN 55126 510(k) NO: K061650 72(TRADITIONAL) PHONE NO : 651-389-0771 SE DECISION MADE: 22-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VECTRA GENISYS VMS FR ENCORE MEDICAL, L.P. ATTN: MICHAEL TREAS 4717 ADAMS ROAD HIXSON, TN 37343 510(k) NO: K062354 73(TRADITIONAL) PHONE NO : 423-870-2281 SE DECISION MADE: 26-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENCORE KNEE SYSTEM IFU ENCORE MEDICAL, L.P. ATTN: TEFFANY HUTTO 9800 METRIC BLVD. AUSTIN, TX 78758 510(k) NO: K063406 74(TRADITIONAL) PHONE NO : 512-834-6225 SE DECISION MADE: 08-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-0 ERBE USA, INC. ATTN: JOHN TARTAL 2225 NORTHWEST PKWY. MARIETTA, GA 30067 510(k) NO: K062712 75(TRADITIONAL) PHONE NO : 770-955-4400 SE DECISION MADE: 26-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HA ETHICON ENDO-SURGERY, LLC ATTN: ELIZABETH MILLER, MST 4545 CREEK ROAD CINCINNATI, OH 45242 510(k) NO: K063192 76(TRADITIONAL) PHONE NO : 513-337-7146 SE DECISION MADE: 30-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EUSURE, EUGLUCO EUMED BIOTECHNOLOGY CO., LTD. ATTN: KE-MIN JEN NO. 58, FU-CHIUN ST. HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) NO: K062892 77(TRADITIONAL) PHONE NO : 886 3 5208829 SE DECISION MADE: 22-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIDERFX EMBOLIC PROTECTION DEVICE EV3 INC ATTN: DAVID WORRELL 9600 54TH AVENUE NORTH PLYMOUTH, MN 55442-2111 510(k) NO: K063785 78(SPECIAL) PHONE NO : 763-398-7000 SE DECISION MADE: 19-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOCOBASE WOUND AND SKIN EMULSION FERNDALE LABORATORIES, INC. ATTN: RICHARD A HAMER 780 WEST EIGHT MILE RD. FERNDALE, MI 48220 510(k) NO: K060272 79(TRADITIONAL) PHONE NO : 248-548-0900 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FLOWCARDIA INC ATTN: DUSTIN MICHAELS 745 N. PASTORIA AVE. SUNNYVALE, CA 94085 510(k) NO: K062868 80(TRADITIONAL) PHONE NO : 408-617-0352 SE DECISION MADE: 19-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMBRO QUICKSET BLOODLINES GAMBRO RENAL PRODUCTS 510(k) NO: K063290 81(TRADITIONAL) 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 9 of 31 ATTN: THOMAS B DOWELL 10810 WEST COLLINS AVE. LAKEWOOD, CO 80215 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... PHONE NO : 303-231-4094 SE DECISION MADE: 30-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMBRO POSICLEAR GAMBRO SERVICES, INC. ATTN: JEFFERY R SHIDEMAN 7307 GLOUCHESTER DRIVE EDINA, MN 55435 510(k) NO: K061782 82(TRADITIONAL) PHONE NO : 952-835-4018 SE DECISION MADE: 04-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SN GEMORE TECHNOLOGY CO., LTD. 510(k) NO: K062675 83(TRADITIONAL) ATTN: TONY C.S. CHANG PHONE NO : 886 2 88091799 11 FL, NO. 29-5, SEC. 2 SE DECISION MADE: 04-JAN-07 CHUNG CHENG E. RD. 510(k) SUMMARY AVAILABLE FROM FDA TAN SHUI, TAIPEI HSIEN, CHINA (TAIWAN) 251 DEVICE: GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 GEN-PROBE, INC. ATTN: E. JOSEPH MCMULLEN 10210 GENETIC CENTER DR. SAN DIEGO, CA 92121-4362 510(k) NO: K063451 84(TRADITIONAL) PHONE NO : 858-410-8649 SE DECISION MADE: 22-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 GEN-PROBE, INC. ATTN: E. JOSEPH MCMULLEN 10210 GENETIC CENTER DR. SAN DIEGO, CA 92121-4362 510(k) NO: K063664 85(TRADITIONAL) PHONE NO : 858-410-8649 SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 GENERIC MEDICAL DEVICE, INC. ATTN: MONICA MONTANEZ 3906 ROSELAND ST. HOUSTON, TX 77006 510(k) NO: K063429 86(TRADITIONAL) PHONE NO : 713-523-9630 SE DECISION MADE: 17-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTABLE X-RAY SYSTEM, MODEL PORT-X II GENORAY CO., LTD. ATTN: CHARLIE MACK 340 SHADY GROVE ROAD FLINTVILLE, TN 37335 510(k) NO: K063121 87(TRADITIONAL) PHONE NO : 931-937-8093 SE DECISION MADE: 11-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SEPRAMESH, MODEL 5959-1214 GENZYME CORPORATION ATTN: MATTHEW HIBBERT 500 KENDALL STREET CAMBRIDGE, MA 02142 510(k) NO: K063739 88(TRADITIONAL) PHONE NO : 617-374-7463 SE DECISION MADE: 17-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GSO BONE FIXATION FASTENERS GOLD STANDARD ORTHOPAEDICS LLC ATTN: DAVID BAUGHMAN 1226 WEST ROWAN ST. LOUISVILLE, KY 40203 510(k) NO: K063589 89(TRADITIONAL) PHONE NO : 502-581-8770 SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPIDTEG TEG-ACT TEST HAEMOSCOPE CORP. ATTN: ELI COHEN 6231 W. HOWARD ST. NILES, IL 60714 510(k) NO: K062604 90(TRADITIONAL) PHONE NO : 847-588-0453 SE DECISION MADE: 31-JAN-07 510(k) STATEMENT DEVICE: 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT HAYES MEDICAL, INC. ATTN: LUKE ROSE 510(k) NO: K070061 91(SPECIAL) PHONE NO : 916-355-7156 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 10 of 31 1115 WINDFIELD WAY, SUITE 100 EL DORADO HILLS, CA 95762-9623 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR) HL RUBBER INDUSTRIES SDN BHD 510(k) NO: K063524 92(TRADITIONAL) ATTN: KENNY HOE PHONE NO : 606 481 1088 LOT 10, KAWASAN SE DECISION MADE: 23-JAN-07 PERINDUSTRIAN DIOH 510(k) STATEMENT KUALA PILAH, NEGERI SEMBILAN, MALAYSIA 72000 DEVICE: TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT HOWMEDICA OSTEONICS ATTN: SHERYL R BAGALIO 325 CORPORATE DRIVE MAHWAH, NJ 07430 510(k) NO: K063423 93(TRADITIONAL) PHONE NO : 201-831-5581 SE DECISION MADE: 22-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM HOYA CONBIO, INC ATTN: DONNA TEMPLEMAN 1105 SUNSET CREEK LANE PLEASANTON, CA 94566 510(k) NO: K063834 94(SPECIAL) PHONE NO : 925-846-0458 SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT HR DENTAL PRODUCTS INC ATTN: JIM RONALDS 21 KENVIEW BLVD, UNIT 9 BRAMPTON, ONTARIO, CANADA L6T 5G7 510(k) NO: K070196 95(TRADITIONAL) PHONE NO : 905 799 0517 SE DECISION MADE: 26-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECL I-FLOW CORP. ATTN: JAMES J DAL PORTO 20202 WINDROW DR. LAKE FOREST, CA 92630 510(k) NO: K063530 96(SPECIAL) PHONE NO : 949-206-2700 SE DECISION MADE: 26-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IKONISCOPE ONCOFISH BLADDER TEST SYSTEM IKONISYS INC ATTN: OSCAR SANCHEZ 5 SCIENCE PARK NEW HAVEN, CT 06511 510(k) NO: K062755 97(TRADITIONAL) PHONE NO : 203-776-0791 SE DECISION MADE: 04-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X3C DIGITAL RADIOGRAPHIC DETECTOR IMAGING DYNAMICS COMPANY LTD. ATTN: SHIRANTHAN SAMARAPPULI 2340 PEGASUS WAY, NE SUITE 151 CALGARY, CANADA T2E 8M5 510(k) NO: K070079 98(SPECIAL) PHONE NO : 403 251 9939 SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS) IMC-HEARTWAY, LLC ATTN: MICHAEL CHEN 6140 MID METRO DRIVE, SUITE 6 FORT MYERS, FL 33912 510(k) NO: K063475 99(ABBREVIATED) PHONE NO : 866-464-9779 SE DECISION MADE: 23-JAN-07 510(k) STATEMENT DEVICE: INION CPS/OTPS FREEDOMPLATE INION OY ATTN: KATI MARTTINEN LAAKARINKATU 2 TAMPERE, FINLAND 33520 510(k) NO: K063410 100(TRADITIONAL) PHONE NO : 358 323 06600 SE DECISION MADE: 23-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARAMOUNT VBR SYSTEM INNOVATIVE SPINAL TECHNOLOGIES INC510(k) NO: K062759 101(TRADITIONAL) ATTN: GINA YEH PHONE NO : 508-452-3520 111FORBES BLVD SE DECISION MADE: 12-JAN-07 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 11 of 31 MANSFIELD, MA 02048 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASK INOVEL LLC ATTN: WILLIAM WARZYNIAK 10111 W. JEFFERSON BLVD. CULVER CITY, CA 90232-3509 510(k) NO: K063747 102(TRADITIONAL) PHONE NO : 866-546-6835 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ULTRACLIP II WING AND ULTRACLIP II COIL INRAD ATTN: MELISSA LALOMIA 4375 DONKER COURT S.E. KENTWOOD, MI 49512 DEVICE: VOLUMETRIC 510(k) NO: K063238 103(TRADITIONAL) PHONE NO : 800-558-4647 SE DECISION MADE: 30-JAN-07 510(k) STATEMENT TOMOGRAPHY INSTRUMENTARIUM DENTAL INC. ATTN: FRANK KASHINSKI 300 WEST EDGERTON AVE. MILWAUKEE, WI 53207-6025 510(k) NO: K063773 104(TRADITIONAL) PHONE NO : 414-747-6315 SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACL TOP INSTRUMENTATION LABORATORY CO. ATTN: CAROL MARBLE 113 HARTWELL AVE. LEXINGTON, MA 02421 510(k) NO: K063679 105(SPECIAL) PHONE NO : 781-861-4467 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS INTEGRA LIFESCIENCES CORP. ATTN: DIANA M BORDON 311 ENTERPRISE DRIVE PLAINSBORO, NJ 08536 510(k) NO: K063124 106(TRADITIONAL) PHONE NO : 609-936-2240 SE DECISION MADE: 19-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTELEPACS INTELERAD MEDICAL SYSTEMS INC. ATTN: ANIBAL JODORCOVSKY 460 STE-CATHERINE WEST SUITE 210 MONTREAL QUEBEC, CANADA M3B 1A7 510(k) NO: K070080 107(TRADITIONAL) PHONE NO : 514 931 6222 SE DECISION MADE: 24-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PENCURE, MODEL VL-7 J. MORITA USA, INC. ATTN: ROBERT A SILVERMAN 1425 K STREET NW SUITE 1100 WASHINGTON, DC 20005 510(k) NO: K063529 108(TRADITIONAL) PHONE NO : 202-783-5070 SE DECISION MADE: 05-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERTONE, MODEL PT-11 JOHARI DIGITAL HEALTHCARE, LTD. ATTN: NISHA JOHARI 26540 W. AGOURA ROAD SUITE 230 CALABASES, CA 91302 510(k) NO: K062439 109(TRADITIONAL) PHONE NO : 818-878-9291 SE DECISION MADE: 08-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FEMORAL INTRAFIX SCREW AND SHEATH JOHNSON & JOHNSON COMPANY ATTN: RUTH FORSTADT 325 PARAMOUNT DRIVE RAYNHAM, MA 02767 510(k) NO: K063577 110(TRADITIONAL) PHONE NO : 508-977-3988 SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K062918 111(TRADITIONAL) ATTN: SUSIE CHEN PHONE NO : 310-348-4201 600 CORPORATE POINTE SE DECISION MADE: 17-JAN-07 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 12 of 31 5TH FLOOR CULVER CITY, CA 90230-7600 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K063585 112(TRADITIONAL) ATTN: SUSIE CHEN PHONE NO : 310-338-8100 600 CORPORATE POINTE SE DECISION MADE: 31-JAN-07 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MO KCI USA, INC. ATTN: CHRISTY HUBBARD OVIATT 8023 VANTAGE DR. SAN ANTONIO, TX 78230-4726 510(k) NO: K063590 113(SPECIAL) PHONE NO : 210-255-6105 SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOGUIDE KMS MEDICAL LLC ATTN: MARIO ARBESU 7290 SW 42ND STREET MIAMI, FL 33155 510(k) NO: K063654 114(TRADITIONAL) PHONE NO : 305-266-3388 SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER LABORATOIRES URGO ATTN: SOPHIE FORTIN 42, RUE DE LONGVIC CHENOVE, FRANCE 21300 510(k) NO: K062559 115(TRADITIONAL) PHONE NO : 33 3 80447967 SE DECISION MADE: 29-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES LASERING S.R.L. ATTN: ALLEN R HOWES 2246 CAMINO RAMON SAN RAMON, CA 94583 510(k) NO: K063396 116(TRADITIONAL) PHONE NO : 925-355-0750 SE DECISION MADE: 17-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO EASYSPINE SYSTEM LDR SPINE USA ATTN: FLOYD G LARSON 11234 EL CAMINO REAL SUITE 200 SAN DIEGO, CA 92130 510(k) NO: K063794 117(SPECIAL) PHONE NO : 858-792-1235 SE DECISION MADE: 24-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HAIRMAX LASERCOMB LEXINGTON INTERNATIONAL, LLC ATTN: EDWARD BASILE 1700 PENNSYLVANIA AVENUE, NW WASHINGTON, DC 20006 510(k) NO: K060305 118(TRADITIONAL) PHONE NO : 202-626-2903 SE DECISION MADE: 18-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSUFLOW DEVICE, MODEL 6198 LEXION MEDICAL, LLC. ATTN: DUANE LLOYD 5000 TOWNSHIP PKWY ST. PAUL, MN 55110 510(k) NO: K063546 119(SPECIAL) PHONE NO : 651-635-0000 SE DECISION MADE: 10-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PILOT SPINAL SYSTEM LIFE SPINE ATTN: REBECCA M BROOKS 2400 HASSELL ROAD SUITE 370 HOFFMAN ESTATES, IL 60169 510(k) NO: K063601 120(TRADITIONAL) PHONE NO : 847-884-6117 SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFECELL DURAL SUBSTITUTE MATRIX LIFECELL CORP. ATTN: REY LIBROJO ONE MILLENIUM WAY BRANCHBURG, NJ 08876 510(k) NO: K061208 121(TRADITIONAL) PHONE NO : 908-947-1114 SE DECISION MADE: 03-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 13 of 31 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... DEVICE: K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING MCNEIL-PPC, INC. ATTN: NADER FOTOUHI PH.D. 199 GRANDVIEW RD. SKILLMAN, NJ 08558 510(k) NO: K062535 122(TRADITIONAL) PHONE NO : 908-904-3730 SE DECISION MADE: 26-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM MEDA LTD. ATTN: EDWARD A KROLL 5905 FAWN LANE CLEVELAND, OH 44141 510(k) NO: K063433 123(TRADITIONAL) PHONE NO : 440-546-9810 SE DECISION MADE: 29-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 210 MEDA LTD. ATTN: EDWARD A KROLL 5905 FAWN LN. CLEVELAND, OH 44141 510(k) NO: K063472 124(TRADITIONAL) PHONE NO : 440-546-9810 SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AG-EDGE, MODEL 91200 MEDEL S.P.A. ATTN: TERRENCE O'BRIEN 112 CAVISTON WAY CARY, NC 27519 510(k) NO: K063103 125(ABBREVIATED) PHONE NO : 919-468-9552 SE DECISION MADE: 08-JAN-07 510(k) STATEMENT DEVICE: SONOTIP II ULTRASOUND NEEDLE SYSTEM MEDI-GLOBE CORPORATION ATTN: SCOTT KARLER 110 WEST ORION #136 TEMPE, AZ 85283 510(k) NO: K070129 126(TRADITIONAL) PHONE NO : 650-463-2900 SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BEAMAX MEDIC SHARPLIGHT LTD. ATTN: DAN LAOR 6 SIRENI STREET HAIFA, ISRAEL 32972 510(k) NO: K063249 127(TRADITIONAL) PHONE NO : 972 4 8246632 SE DECISION MADE: 17-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE MEDICAL DEVICE MANUFACTURER (THAIL510(k) NO: K062780 128(ABBREVIATED) ATTN: OYTIP KUNWUNLOP PHONE NO : 661 844 7959 7/145 MOO 4 SE DECISION MADE: 05-JAN-07 AMATA CITY INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA RAYONG, THAILAND 21140 DEVICE: LUMINEX LL LASER SYSTEM MEDICAL LASER SYSTEMS INC ATTN: MIKI KOLTON 800 CONNECTICUT AVE. NW SUITE 500 WAHINGTON, DC 20006 510(k) NO: K063574 129(TRADITIONAL) PHONE NO : 202-331-3134 SE DECISION MADE: 29-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEXNRG XFR MEDICNRG LTD. ATTN: GEORGE J HATTUB 291 HILLSIDE AVE. SOMERSET, MA 02726 510(k) NO: K063843 130(SPECIAL) PHONE NO : 508-479-6116 SE DECISION MADE: 03-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-JAWS CERVICAL COMPRESSIVE MINI FRAME MEDICREA TECHNOLOGIES ATTN: J.D. WEBB 1001 OAKWOOD BLVD. ROUND ROCK, TX 78681 510(k) NO: K062181 131(TRADITIONAL) PHONE NO : 512-388-0199 SE DECISION MADE: 16-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 14 of 31 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... DEVICE: ACTIM PROM AND CONTROLS MEDIX BIOCHEMICA ATTN: CYNTHIA SINCLAIR 49 PLAIN STREET NORTH ATTLEBORO, MA 02760 510(k) NO: K061886 132(TRADITIONAL) PHONE NO : 508-643-0434 SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAPMAN LAPAROSCOPE MANIPULATOR AND ACCESSORIES, MODEL 900-200 SE MEDSYS, S.A. ATTN: JEFF MORGAN 13723 DANA LN. EAST PUYALLUP, WA 98373 510(k) NO: K062968 133(SPECIAL) PHONE NO : 253-535-9369 SE DECISION MADE: 03-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFEPAK 12 DEFIBRILLATOR/MONITOR MEDTRONIC EMERGENCY RESPONSE SYSTE510(k) NO: K063510 134(SPECIAL) ATTN: MICHELLE ACKERMANN PHONE NO : 425-867-4744 11811 WILLOWS RD., N.E. SE DECISION MADE: 26-JAN-07 P.O. BOX 97006 510(k) SUMMARY AVAILABLE FROM FDA REDMOND, WA 98073-9706 DEVICE: MODIFICATION TO: SATELLITE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK ATTN: RICHARD TREHARNE 1800 PYRAMID PLACE MEMPHIS, TN 38132 510(k) NO: K060415 135(TRADITIONAL) PHONE NO : 219-396-3133 SE DECISION MADE: 05-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK ATTN: LEE GRANT 1800 PYRAMID PLACE MEMPHIS, TN 38132 510(k) NO: K063417 136(SPECIAL) PHONE NO : 901-396-3133 SE DECISION MADE: 18-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE MERETE MEDICAL GMBH ATTN: DONNA COLEMAN 49 PURCHASE STREET RYE, NY 10580 510(k) NO: K063487 137(TRADITIONAL) PHONE NO : 914-967-1532 SE DECISION MADE: 22-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOCK IT! ORAL PAIN GEL MERLIN GROUP DBA MCMERLIN DENTAL C510(k) NO: K063148 138(TRADITIONAL) ATTN: EILEEN VENNUM PHONE NO : 972-602-3746 1610 W. POLO RD SE DECISION MADE: 17-JAN-07 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA GRAND PRAIRIE, TX 75052 DEVICE: TENDER FIBER MICERIUM S.P.A. ATTN: EUGENIO MICELI VIA MARCONI 83 AVENGO, ITALY 16030 510(k) NO: K063170 139(TRADITIONAL) PHONE NO : 39 018 57887870 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROTEK MEDICAL SURGICAL GOWN/TOGA MICROTEK MEDICAL, INC. ATTN: THOMAS BONNER 512 LEHMBERG RD. COLUMBUS, MS 39702 510(k) NO: K062899 140(TRADITIONAL) PHONE NO : 800-844-0988 SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRUS MICROCOIL SYSTEM, "CASHMERE" MODEL SRC MICRUS ENDOVASCULAR CORPORATION ATTN: PATRICK LEE 821 FOX LANE SAN JOSE, CA 95131 510(k) NO: K063653 141(SPECIAL) PHONE NO : 408-433-1400 SE DECISION MADE: 17-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER MIMOSA ACOUSTICS, INC. 510(k) NO: K063338 142(TRADITIONAL) 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 15 of 31 ATTN: PATRICIA S JENG 60 HAZELWOOD DR., SUITE #209 CHAMPAIGN, IL 61820 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... PHONE NO : 217-367-9740 SE DECISION MADE: 04-JAN-07 510(k) STATEMENT DEVICE: MEPILEX AG ABSORBENT SILICONE-COATED DRESSING MOLNLYCKE HEALTH CARE ATTN: STEVEN DOWDLEY 5550 PEACHTREE PARKWAY SUITE 500 NORCROSS, GA 30092 510(k) NO: K061554 143(TRADITIONAL) PHONE NO : 678-250-7930 SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOORLDLS LASER DOPPLER LINE SCANNER MOOR INSTRUMENTS LTD. 510(k) NO: K063561 144(TRADITIONAL) ATTN: XIABING HUANG PHONE NO : 44 129 735715 MILLWEY SE DECISION MADE: 19-JAN-07 AXMINSTER, DEVON, UNITED KINGDOM E510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOORFLPI FULL-FIELD LASER PERFUSION IMAGER MOOR INSTRUMENTS LTD. 510(k) NO: K063586 145(TRADITIONAL) ATTN: XIABING HUANG PHONE NO : 44 129 735715 MILLWEY SE DECISION MADE: 25-JAN-07 AXMINSTER, DEVON, UNITED KINGDOM E510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS MTD, INC. ATTN: CHRISTINE NICHOLS 8 CROWNVIEW COURT SPARTA, NJ 07871 510(k) NO: K063439 146(TRADITIONAL) PHONE NO : 973-726-7679 SE DECISION MADE: 22-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEATSTITCH NEATCLOSE SUTURING DEVICE NEAT STITCH LTD. ATTN: YOSSI MUNCHER, PH.D. HAHADAS 1 ST OR AKIVA, ISRAEL 30600 510(k) NO: K063462 147(TRADITIONAL) PHONE NO : 972 462 62876 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIPRO SAFETOUCH II GAMMA NIPRO MEDICAL CORP. ATTN: JESSICA OSWALD 3150 NW 107 AVE.. MIAMI, FL 33172 510(k) NO: K063721 148(SPECIAL) PHONE NO : 305-599-7174 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SFB AND CFB IMPLANTS - 5.0 PLATFORM NOBEL ATTN: 22715 YORBA BIOCARE AB HERBERT CRANE SAVI RANCH PKWY. LINDA, CA 92887 510(k) NO: K063718 149(SPECIAL) PHONE NO : 714-282-5074 SE DECISION MADE: 05-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1 NORDICICEMEDICAL AS ATTN: JAMES W KNOX 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 510(k) NO: K063539 150(TRADITIONAL) PHONE NO : 508-643-0434 SE DECISION MADE: 17-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUTRON THERAPY SYSTEM NORTHERN ILLINOIS UNIV. OUTREACH ATTN: JONATHAN S KAHAN 555 THIRTEENTH ST., NW WASHINGTON, DC 20004 510(k) NO: K063691 151(TRADITIONAL) PHONE NO : 202-637-5794 SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM NOVA BIOMEDICAL CORP. ATTN: PAUL W MACDONALD, PHD 200 PROSPECT ST. WALTHAM, MA 02454-9141 510(k) NO: K063821 152(TRADITIONAL) PHONE NO : 781-894-0800 SE DECISION MADE: 24-JAN-07 510(k) STATEMENT 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 16 of 31 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... DEVICE: SPY IMAGING SYSTEM NOVADAQ TECHNOLOGIES, INC. 510(k) NO: K063345 153(TRADITIONAL) ATTN: ALLISON MANNERS PHONE NO : 905 629 3822 2585 SKYMARK AVENUE, STE. 306 SE DECISION MADE: 12-JAN-07 MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE ACP4 SYSTEM NUVASIVE, INC. ATTN: LAETITIA COUSIN 4545 TOWNE CENTRE CT. SAN DIEGO, CA 92121 510(k) NO: K062590 154(SPECIAL) PHONE NO : 858-909-1868 SE DECISION MADE: 18-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM NUVASIVE, INC. ATTN: LAETITIA COUSIN 4545 TOWNE CENTRE CT. SAN DIEGO, CA 92121 510(k) NO: K062765 155(SPECIAL) PHONE NO : 858-909-1968 SE DECISION MADE: 24-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSFERION OLYMPUS AMERICA, INC. ATTN: LAURA STORMS-TYLER 3500 CORPORATE PKWY. P.O. BOX 610 CENTER VALLEY, PA 18034-0610 510(k) NO: K061499 156(TRADITIONAL) PHONE NO : 631-844-5688 SE DECISION MADE: 26-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER OMNIGUIDE, INC. ATTN: DOUGLAS W WOODRUFF ONE KENDALL SQUARE, BLDG 100 3RD FLOOR CAMBRIDGE, MA 02139 510(k) NO: K070071 157(TRADITIONAL) PHONE NO : 617-551-8404 SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS ORTHO DEVELOPMENT CORP. ATTN: WILLIAM J GRIFFIN 12187 SOUTH BUSINESS PARK DR. DRAPER, UT 84020 510(k) NO: K062666 158(TRADITIONAL) PHONE NO : 801-619-3470 SE DECISION MADE: 25-JAN-07 510(k) STATEMENT DEVICE: EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM ORTHO DEVELOPMENT CORP. ATTN: WILLIAM J GRIFFIN 12187 SOUTH BUSINESS PARK DR. DRAPER, UT 84020 510(k) NO: K062775 159(TRADITIONAL) PHONE NO : 801-619-3470 SE DECISION MADE: 16-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CA ORTHO-CLINICAL DIAGNOSTICS ATTN: MARLENE HANNA 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 510(k) NO: K062165 160(TRADITIONAL) PHONE NO : 585-453-4041 SE DECISION MADE: 05-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TS-BONE HIP TOOL ORTHOPEDIC SCIENCES, INC ATTN: JAMES K BRANNON 3020 OLD RANCH PARKWAY SUITE 325 SEAL BEACH, CA 90740 510(k) NO: K063709 161(SPECIAL) PHONE NO : 562-799-5550 SE DECISION MADE: 04-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: OSSEO SCIENTIFIC, LLC ATTN: MICHAEL FELDMAN 3138 VEEDER AVE. TOMS RIVER, NJ 08753 510(k) NO: K070155 162(TRADITIONAL) PHONE NO : 201-490-5421 SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 17 of 31 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... DEVICE: EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), M PACIFIC CONSOLIDATED INDUSTRIES, L510(k) NO: K061414 163(TRADITIONAL) ATTN: GARY CLARK PHONE NO : 951-479-0872 12201 MAGNOLIA AVE. SE DECISION MADE: 22-JAN-07 RIVERSIDE, CA 92503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAJUNKS STIMULONG TSUI-METHOD SET PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K062900 164(TRADITIONAL) ATTN: CHRISTIAN QUASS PHONE NO : 49 770 49291586 KARL-HALL-STRASSE 01 SE DECISION MADE: 12-JAN-07 GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TROCASYS PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K063528 165(TRADITIONAL) ATTN: CHRISTIAN QUASS PHONE NO : 49 770 48291 KARL-HALL-STRASSE 01 SE DECISION MADE: 17-JAN-07 GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50 PDG PRODUCT DESIGN GROUP, INC. ATTN: EDWARD A KROLL 5905 FAWN LANE CLEVELAND, OH 44141 510(k) NO: K063736 166(TRADITIONAL) PHONE NO : 440-546-9810 SE DECISION MADE: 17-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COSMELIGHT PENNTACK ENTERPRISES INC. ATTN: PABLO PENA 3321 N.W. 79TH ST. MIAMI, FL 33147 510(k) NO: K061720 167(TRADITIONAL) PHONE NO : 305-835-0411 SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREMIO PETERS SURGICAL ATTN: ANNIE LASSERRE 42 RUE BENOIT FRACHON Z.I. LES VIGNES BOBIGNY, FRANCE 93013 510(k) NO: K060465 168(TRADITIONAL) PHONE NO : 33 148 106259 SE DECISION MADE: 17-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEARTSTART MRX, MODELS M3535A OR M3536A PHILIPS MEDICAL SYSTEMS ATTN: DENISE HALEY 3000 MINUTEMAN RD. ANDOVER, MA 01810-1099 510(k) NO: K063375 169(SPECIAL) PHONE NO : 978-659-4358 SE DECISION MADE: 11-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 PHILIPS MEDICAL SYSTEMS ATTN: JOSEPH S ARNAUDO 22100 BOTHELL EVERETT HWY BOTHELL, WA 98021-8431 510(k) NO: K063559 170(TRADITIONAL) PHONE NO : 425-482-8958 SE DECISION MADE: 04-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K063781 171(TRADITIONAL) ATTN: LYNN HARMER PHONE NO : 425-487-7312 22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 05-JAN-07 BOTHELL, WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS POLYMER TECHNOLOGY SYSTEMS, INC. ATTN: MARGO ENRIGHT 7736 ZIONSVILLE RD. INDIANAPOLIS, IN 46268 510(k) NO: K070017 172(SPECIAL) PHONE NO : 317-870-5610 SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 18 of 31 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... DEVICE: PORTLAND COBALT CHROME FEMORAL HEAD PORTLAND ORTHOPAEDICS LIMITED ATTN: ELAINE DUNCAN P.O. BOX 560 STILLWATER, MN 55082 510(k) NO: K063278 173(TRADITIONAL) PHONE NO : 715-549-6035 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER EXTENDERS MODEL# PEC200, PES200,PES200S POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K063746 174(SPECIAL) ATTN: BARBARA WHITMAN PHONE NO : 267-775-8151 2021 CABOT BLVD. SE DECISION MADE: 12-JAN-07 LANGHORNE, PA 19047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMATHERAPY, MODEL 22216 PRECISION FABRICS GROUP, INC. ATTN: PAMELA J WEAGRAFF 18 BRIDIE LANE NORFOLK, MA 02056 510(k) NO: K061242 175(TRADITIONAL) PHONE NO : 508-528-1745 SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PR 510(k) NO: K061678 176(TRADITIONAL) PHONE NO : 631-981-3907 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA PRORHYTHM ATTN: JOHN J TALARICO 105 COMAC ST. RONKONKOMA, NY 11779 DEVICE: REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM 510(k) NO: K063405 177(SPECIAL) PHONE NO : 650-298-0748 SE DECISION MADE: 08-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA RADIANT MEDICAL ATTN: SCOTT A WILSON 250 CHESAPEAKE DR. REDWOOD CITY, CA 94063 DEVICE: TOPACS RADIOLOGICAL SPECIALISTS, INC. ATTN: FRANK MCMURRAY 5920 NOBLE AVE. VAN NUYS, CA 91411 DEVICE: TOSCA 500 TCPCO2, 510(k) NO: K063294 178(TRADITIONAL) PHONE NO : 818-908-9000 SE DECISION MADE: 24-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA SPO2 AND PULSE RATE MONITORING SYSTEM RADIOMETER BASEL AG ATTN: JEAN-PIERRE PALMA AUSTRASSE 25 BASEL, SWITZERLAND 4051 510(k) NO: K063434 179(TRADITIONAL) PHONE NO : 011 416 12788207 SE DECISION MADE: 22-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COR ANALYZER 1, VERSION 1.4 RCADIA MEDICAL IMAGING LTD. ATTN: DAN LAOR DERECH YAFO 157 HAIFA, ISRAEL 35251 510(k) NO: K063548 180(TRADITIONAL) PHONE NO : 972 4 8246632 SE DECISION MADE: 22-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRAXEL II SR LASER SYSTEM RELIANT TECHNOLOGIES, INC. ATTN: HEATHER TANNER 464 ELLIS ST. MOUNTAIN VIEW, CA 94043 510(k) NO: K062303 181(TRADITIONAL) PHONE NO : 650-641-5861 SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBAS INTEGRA C 111 ROCHDIAG ATTN: CORINA HARPER 9115 HAGUE RD. INDIANAPOLIS, IN 46250-0457 510(k) NO: K063744 182(SPECIAL) PHONE NO : 317-521-3831 SE DECISION MADE: 17-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERULOPLASMIN, MODEL 2055953 ROCHE DIAGNOSTICS CORP. ATTN: CORINA HARPER 510(k) NO: K062114 183(TRADITIONAL) PHONE NO : 317-521-3831 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 19 of 31 9115 HAGUE RD. INDIANAPOLIS, IN 46250 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBAS INTEGRA CERULOPLASMIN ROCHE DIAGNOSTICS CORP. ATTN: CORINA HARPER 9115 HAGUE RD. INDIANAPOLIS, IN 46250 510(k) NO: K062379 184(TRADITIONAL) PHONE NO : 317-521-3831 SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COAGUCHEK XS SYSTEM ROCHE DIAGNOSTICS CORP. ATTN: THERESA BUSH 9115 HAGUE RD. INDIANAPOLIS, IN 46256 510(k) NO: K062925 185(TRADITIONAL) PHONE NO : 317-521-3742 SE DECISION MADE: 29-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COAGUCHEK XS PT CONTROLS ROCHE DIAGNOSTICS CORP. ATTN: THERESA AMBROSE BUSH 9115 HAGUE RD. INDIANAPOLIS, IN 46250 510(k) NO: K063823 186(TRADITIONAL) PHONE NO : 307-521-3723 SE DECISION MADE: 29-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS SANARUS MEDICAL, INC. ATTN: ALAN MARQUARDT 4696 WILLOW RD. PLEASANTON, CA 94588 510(k) NO: K062896 187(TRADITIONAL) PHONE NO : 925-460-6080 SE DECISION MADE: 03-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASTRA 300 SDI DIAGNOSTICS, INC. ATTN: COSIMO CARIOLO 10 HAMPDEN DR. EASTON, MA 02375 510(k) NO: K061571 188(TRADITIONAL) PHONE NO : 508-238-7033 SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASTRAGUARD PULMONARY FUNCTION FILTER SDI DIAGNOSTICS, INC. ATTN: COSIMO CARIOLO 10 HAMPDEN DR. EASTON, MA 02375 510(k) NO: K062913 189(TRADITIONAL) PHONE NO : 508-238-7033 SE DECISION MADE: 26-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS SERADYN INC. ATTN: JACK ROGERS 7998 GEORGETOWN RD. SUITE 1000 INDIANAPOLIS, IN 46268-5260 510(k) NO: K062966 190(TRADITIONAL) PHONE NO : 317-610-3823 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION SHIJIAZHUANG LIANHE SHUNDA PLASTIC510(k) NO: K070044 191(TRADITIONAL) ATTN: KATHY LIU PHONE NO : 909-591-7888 3973 SCHAEFER AVE SE DECISION MADE: 29-JAN-07 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY SIEMENS AG, MEDICAL SOLUTIONS ATTN: KRISTIN FROWEIN SIEMENSSTRASSE 1 FORCHHEIM, GERMANY D 91301 510(k) NO: K063762 192(TRADITIONAL) PHONE NO : 49 919 1189638 SE DECISION MADE: 05-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K063761 193(TRADITIONAL) ATTN: MICHAELA MAHL PHONE NO : 650-694-5653 1230 SHOREBIRD WAY SE DECISION MADE: 04-JAN-07 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 20 of 31 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... THIRD PARTY REVIEW DEVICE: SYNGO MI APPLICATIONS 2007A SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K063826 194(SPECIAL) ATTN: FRANK POKROP PHONE NO : 847-304-7516 2501 NORTH BARRINGTON RD. SE DECISION MADE: 12-JAN-07 HOFFMAN ESTATES, IL 60195-7372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K063803 195(TRADITIONAL) ATTN: MICHAELA MAHL PHONE NO : 650-694-5653 1230 SHOREBIRD WAY SE DECISION MADE: 05-JAN-07 P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA MOUNTAIN VIEW, CA 94039-7393 THIRD PARTY REVIEW DEVICE: SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM SMITH & NEPHEW, INC. ATTN: KATHLEEN BURNS 150 MINUTEMAN RD. ANDOVER, MA 01810 510(k) NO: K062849 196(TRADITIONAL) PHONE NO : 978-474-6301 SE DECISION MADE: 19-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, SMITHS MEDICAL ASD, INC. ATTN: BRIAN FARIAS 10 BOWMAN DR. KEENE, NH 03431 510(k) NO: K063450 197(ABBREVIATED) PHONE NO : 603-352-3812 SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S1 SOLARIS MEDICAL TECHNOLOGY, INC. ATTN: THOMAS KROENKE 2355 EAST FLAMINGO ROAD SUITE 201 G LAS VEGAS, NV 89119 510(k) NO: K061931 198(TRADITIONAL) PHONE NO : 303-956-4232 SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMNOSCREEN SOMNOMEDICS GMBH & CO. KG ATTN: CHERITA JAMES 719 A STREET NE WASHINGTON, DC 20002 510(k) NO: K060708 199(TRADITIONAL) PHONE NO : 202-546-1262 SE DECISION MADE: 24-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MIC SORIN GROUP ITALIA S.R.L ATTN: BARRY SALL 200 WEST STREET WALTHAM, MA 02451 510(k) NO: K063255 200(TRADITIONAL) PHONE NO : 781-434-4742 SE DECISION MADE: 11-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETE SPIRE BIOMEDICAL INC ATTN: SHEKHAR D NIMKAR ONE PATRIOTS PARK BEDFORD, MA 01730 510(k) NO: K063431 201(TRADITIONAL) PHONE NO : 781-275-6001 SE DECISION MADE: 29-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STEAMPLUS STEAM INTEGRATOR SPS MEDICAL SUPPLY CORP. ATTN: GARY J SOCOLA 6789 WEST HENRIETTA RD. RUSH, NY 14543 510(k) NO: K063799 202(TRADITIONAL) PHONE NO : 585-359-0130 SE DECISION MADE: 05-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT STELKAST COMPANY ATTN: DAVID J STUMPO 200 HIDDEN VALLEY RD. MCMURRAY, PA 15317 510(k) NO: K063211 203(TRADITIONAL) PHONE NO : 724-941-6368 SE DECISION MADE: 18-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 21 of 31 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... DEVICE: STRAUMANN PREFGEL STRAUMANN USA ATTN: LISA M QUAGLIA 60 MINUTETEMAN ROAD ANDOVER, MA 01810 510(k) NO: K063812 204(SPECIAL) PHONE NO : 978-747-2575 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLEX P BONE CEMENT STRYKER ORTHOPAEDICS ATTN: TIFFANI D ROGERS 325 CORPORATE DRIVE MAHWAH, NJ 07430 510(k) NO: K062553 205(TRADITIONAL) PHONE NO : 201-831-5612 SE DECISION MADE: 08-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO HIPSTAR FEMORAL STEM STRYKER ORTHOPAEDICS ATTN: TIFFANI ROGERS 325 CORPORATE DRIVE MAHWAH, NJ 07430 510(k) NO: K063822 206(SPECIAL) PHONE NO : 201-831-5612 SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVE SUPER SAFE PLASTIC PRODUCTS CO., L510(k) NO: K070035 207(TRADITIONAL) ATTN: KATHY LIU PHONE NO : 909-591-7888 3973 SCHAEFER AVE SE DECISION MADE: 23-JAN-07 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE SUPER SAFE PLASTIC PRODUCTS CO., L510(k) NO: K070040 208(TRADITIONAL) ATTN: KATHY LIU PHONE NO : 909-591-7888 3973 SCHAEFER AVE SE DECISION MADE: 26-JAN-07 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSEAL PTC TRIO SURGRX, INC. ATTN: LINDA OLESON 101 SAGINAW DR. REDWOOD CITY, CA 94063 510(k) NO: K070165 209(SPECIAL) PHONE NO : 650-482-2400 SE DECISION MADE: 29-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TISSUE SITE MARKING SYSTEM SUROS SURGICAL SYSTEMS, INC. ATTN: HEIDI STRUNK 6100 TECHNOLOGY CENTER DR. INDIANAPOLIS, IN 46278 510(k) NO: K062528 210(TRADITIONAL) PHONE NO : 317-344-7500 SE DECISION MADE: 26-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINGLOCK SYBRON DENTAL SPECIALTIES ATTN: COLLEEN BOSWELL 100 BAYVIEW CIRCLE SUITE 6000 NEWPORT BEACH, CA 92660-8915 510(k) NO: K061042 211(TRADITIONAL) PHONE NO : 949-255-8766 SE DECISION MADE: 19-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM SYNTHES (USA) ATTN: DEBORAH L JACKSON 1301 GOSHEN PKWY WEST CHESTER, PA 19380 510(k) NO: K063181 212(TRADITIONAL) PHONE NO : 610-719-6948 SE DECISION MADE: 05-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES ORACLE SPACER SYNTHES SPINE CO.LP ATTN: BONNIE J SMITH 1302 WRIGHTS LANE EAST WEST CHESTER, PA 19380 510(k) NO: K062933 213(TRADITIONAL) PHONE NO : 610-719-5725 SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K062800 214(TRADITIONAL) 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 22 of 31 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... ATTN: PI-SHIOU LI PHONE NO : 886 266 358080 4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 12-JAN-07 SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TECO MICROALBUMIN 2-1 COMBO STRIPS TECO DIAGNOSTICS ATTN: JIAN VAECHES 1268 NORTH LAKEVIEW AVE. ANAHEIM, CA 92807 510(k) NO: K061419 215(TRADITIONAL) PHONE NO : 714-693-7788 SE DECISION MADE: 26-JAN-07 510(k) STATEMENT DEVICE: VSPSPN TECRES SPA ATTN: CHRISTINE BRAUER 1700 RESEARCH BOULEVARD SUITE 220 ROCKVILLE, MD 20850 510(k) NO: K063438 216(TRADITIONAL) PHONE NO : 301-545-1990 SE DECISION MADE: 17-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIFOCUS GLIDEWIRE ADVANTAGE TERUMO MEDICAL CORP. ATTN: MARK UNTERREINER 950 ELKTON BLVD. ELKTON, MD 21921 510(k) NO: K063372 217(SPECIAL) PHONE NO : 410-392-7213 SE DECISION MADE: 19-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM THE ANSPACH EFFORT, INC. ATTN: JAMES CARBONE 4500 RIVERSIDE DR. PALM BEACH GARDENS, FL 33410 510(k) NO: K061297 218(TRADITIONAL) PHONE NO : 561-627-1080 SE DECISION MADE: 26-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE THE ANSPACH EFFORT, INC. ATTN: JIM BANIC 4500 RIVERSIDE DR. PALM BEACH GARDENS, FL 33410 510(k) NO: K063688 219(SPECIAL) PHONE NO : 561-627-1080 SE DECISION MADE: 16-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPI ELEMENT PLATFORM O 4.0 MM THOMMEN MEDICAL, AG ATTN: FLOYD G LARSON 11234 EL CAMINO REAL, STE. 200 SAN DIEGO, CA 92130 510(k) NO: K070007 220(SPECIAL) PHONE NO : 858-792-1235 SE DECISION MADE: 10-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM TOPEX, INC ATTN: ANTHONY PELLEGRINA 10 PRECISION ROAD DANBURY, CT 06810 510(k) NO: K063456 221(TRADITIONAL) PHONE NO : 203-748-5918 SE DECISION MADE: 09-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXCEL FLOW TRI DENTAL INNOVATORS ATTN: LINDA NGUYEN 13902 WEST ST., UNIT C GARDEN GROVE, CA 92843 510(k) NO: K063714 222(TRADITIONAL) PHONE NO : 714-554-1170 SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) TRIPATH IMAGING ATTN: BRYAN J TUCKER 4025 STIRRUP CREEK DR. SUITE 400 DURHAM, NC 27703 510(k) NO: K061613 223(TRADITIONAL) PHONE NO : 919-206-7101 SE DECISION MADE: 10-JAN-07 510(k) STATEMENT DEVICE: TRU-CABLE TRUPHATEK INTERNATIONAL, LTD. ATTN: PAUL DRYDEN 3460 POINTE CREEK CT. 510(k) NO: K063309 224(TRADITIONAL) PHONE NO : 239-498-2155 SE DECISION MADE: 12-JAN-07 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 23 of 31 # 102 BONITA SPRINGS, FL 34134 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING TYCO HEALTHCARE GROUP ATTN: ROBERT ZOTT 150 GLOVER AVE. NORWALK, CT 06856 510(k) NO: K063536 225(TRADITIONAL) PHONE NO : 203-845-4515 SE DECISION MADE: 29-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U2 HIP STEM, TI PLASMA SPRAY UNITED ORTHOPEDIC CORP. ATTN: GENE HUANG 57 PARK AVE. 2, SCIENCE PARK HSINCHU, CHINA (TAIWAN) 300 510(k) NO: K062978 226(TRADITIONAL) PHONE NO : 886 3 5773351 SE DECISION MADE: 16-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYGLUCO, MODEL IGM-0002 G2 US DIAGNOSTICS, INC. ATTN: EDWARD LETKO 304 PARK AVENUE SOUTH SUITE 218 NEW YORK, NY 10010-4301 510(k) NO: K061431 227(TRADITIONAL) PHONE NO : 212-674-3636 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905 VASCULAR SOLUTIONS, INC. ATTN: PATRICE STROMBERG 6464 SYCAMORE COURT NORTH MINNEAPOLIS, MN 55369 510(k) NO: K062627 228(TRADITIONAL) PHONE NO : 763-656-4300 SE DECISION MADE: 05-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230 VASCULAR SOLUTIONS, INC. ATTN: JULIE TAPPER 6464 SYCAMORE COURT NORTH MINNEAPOLIS, MN 55369 510(k) NO: K062877 229(TRADITIONAL) PHONE NO : 763-656-4228 SE DECISION MADE: 18-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTO-FILL SYRINGE KIT, MODEL 7600 VASCULAR SOLUTIONS, INC. ATTN: PATRICE STROMBERG 6464 SYCAMORE COURT NORTH MINNEAPOLIS, MN 55369 510(k) NO: K063851 230(TRADITIONAL) PHONE NO : 763-656-4300 SE DECISION MADE: 26-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTIFLEX SPINAL SCREW SYSTEM VERTIFLEX (TM), INCORPORATED ATTN: STEVE REITZLER 1954 KELLOGG AVENUE, SUITE 100 CARLSBAD, CA 92008 510(k) NO: K062670 231(TRADITIONAL) PHONE NO : 760-448-4800 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ-MIO STERNAL VIDACARE CORPORATION ATTN: GRACE HOLLAND 3722 AVE. SAUSALITO IRVINE, CA 92606 510(k) NO: K063567 232(TRADITIONAL) PHONE NO : 949-262-0411 SE DECISION MADE: 26-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 VISION BIOSYSTEMS INC. ATTN: RONALD F LAGERQUIST 1833 PORTOLA ROAD VENTURA, CA 93003 510(k) NO: K062615 233(ABBREVIATED) PHONE NO : 805-499-6758 SE DECISION MADE: 29-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERON PLUS VOCO GMBH ATTN: MICHAEL SUS ANTON-FLETTNER-STRASSE 1-3 CUXHAVEN, GERMANY D-27472 510(k) NO: K063554 234(ABBREVIATED) PHONE NO : 49 472 1719214 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 24 of 31 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... DEVICE: TWINKY STAR NF VOCO GMBH ATTN: MANFRED THOMAS PLAUMANN ANTON-FLETTNER-STRASSE 1-3 CUXHAVEN, GERMANY D-27472 510(k) NO: K063604 235(ABBREVIATED) PHONE NO : 49 472 17190 SE DECISION MADE: 22-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER VOLUME INTERACTIONS PTE LTD 510(k) NO: K063730 236(SPECIAL) ATTN: VALERIE FAN PHONE NO : 65 622 26962 1 KIM SENG PROMENADE SE DECISION MADE: 31-JAN-07 #12-01 GREAT WORLD CITY EAST 510(k) STATEMENT TOWER, SINGAPORE, SINGAPORE 237994 DEVICE: WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODE WAKO CHEMICALS, USA, INC. ATTN: LORI CREASY 1600 BELLWOOD ROAD RICHMOND, VA 23237 510(k) NO: K062368 237(TRADITIONAL) PHONE NO : 804-714-1932 SE DECISION MADE: 31-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT P WALTER LORENZ SURGICAL, INC. ATTN: KIM REED 1520 TRADEPORT DR. JACKSONVILLE, FL 32218 510(k) NO: K063052 238(TRADITIONAL) PHONE NO : 904-741-4400 SE DECISION MADE: 12-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE WILLIAM COOK EUROPE APS ATTN: TINA H ANDERSON SANDET 6, DK-4632 BJAEVERSKOV, DENMARK 510(k) NO: K061670 239(SPECIAL) PHONE NO : 45 56 868760 SE DECISION MADE: 19-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUSION QUATTRO EXTRACTION BALLOON XL WILSON-COOK MEDICAL, INC. ATTN: SCOTTIE FARIOLE 4900 BETHANIA STATION RD. WINSTON-SALEM, NC 27105 510(k) NO: K063677 240(SPECIAL) PHONE NO : 336-744-0157 SE DECISION MADE: 05-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HILGER DUAL-STIM NERVE STIMULATOR WR MEDICAL ELECTRONICS CO. ATTN: GARY SYRING 800 LAVANGER LANE STOUGHTON, WI 53589 510(k) NO: K063560 241(ABBREVIATED) PHONE NO : 608-877-2635 SE DECISION MADE: 05-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XODUS MEDICAL ANTI-FOG SOLUTION XODUS MEDICAL, INC. ATTN: BRENDA NIEL 702 PROMINENCE DR. NEW KENSINGTON, PA 15068 510(k) NO: K063587 242(TRADITIONAL) PHONE NO : 724-337-5500 SE DECISION MADE: 09-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER Z-MEDICA CORPORATION ATTN: GIACOMO BASADONNA 4 FAIRFIELD BLVD. WALLINGFORD, CT 06492 510(k) NO: K070010 243(SPECIAL) PHONE NO : 203-294-0000 SE DECISION MADE: 25-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES ZIBO HENGDE PLASTIC & RUBBER PRODU510(k) NO: K070006 244(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 NO. 209 BEI SI HUAN ZHONG ROAD SE DECISION MADE: 19-JAN-07 BEIJING, CHINA 10083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY ZIMMER, INC. 510(k) NO: K063251 245(TRADITIONAL) 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 25 of 31 ATTN: DALENE T BINKLEY P.O. BOX 708 WARSAW, IN 46581-0708 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... PHONE NO : 574-372-4907 SE DECISION MADE: 24-JAN-07 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD TOTAL WITH SUMMARIES TOTAL WITH STATEMENTS 245 230 15 Links on this page: 1. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062027.pdf 2. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063782.pdf 3. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062009.pdf 4. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063409.pdf 5. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063285.pdf 6. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063829.pdf 7. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062511.pdf 8. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062907.pdf 9. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062544.pdf 10. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063058.pdf 11. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063370.pdf 12. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063819.pdf 13. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062497.pdf 14. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063630.pdf 15. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062996.pdf 16. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063470.pdf 17. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062363.pdf 18. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063217.pdf 19. http://www.accessdata.fda.gov/cdrh_docs/pdf5/K052973.pdf 20. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062937.pdf 21. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063573.pdf 22. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063300.pdf 23. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063196.pdf 24. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063666.pdf 25. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060818.pdf 26. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K061898.pdf 27. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063597.pdf 28. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063623.pdf 29. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062998.pdf 30. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063732.pdf 31. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062530.pdf 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 26 of 31 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... 32. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062318.pdf 33. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K061602.pdf 34. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063780.pdf 35. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062289.pdf 36. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062358.pdf 37. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063476.pdf 38. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063018.pdf 39. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063377.pdf 40. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063632.pdf 41. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063717.pdf 42. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063644.pdf 43. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063378.pdf 44. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062503.pdf 45. http://www.accessdata.fda.gov/cdrh_docs/pdf7/K070093.pdf 46. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062046.pdf 47. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063774.pdf 48. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062082.pdf 49. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063326.pdf 50. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K061430.pdf 51. http://www.accessdata.fda.gov/cdrh_docs/pdf7/K070063.pdf 52. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063235.pdf 53. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063621.pdf 54. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063272.pdf 55. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063322.pdf 56. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063351.pdf 57. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063508.pdf 58. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063610.pdf 59. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063525.pdf 60. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062099.pdf 61. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062397.pdf 62. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063483.pdf 63. http://www.accessdata.fda.gov/cdrh_docs/pdf7/K070019.pdf 64. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063509.pdf 65. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063741.pdf 66. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063208.pdf 67. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063828.pdf 68. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062176.pdf 69. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063846.pdf 70. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063797.pdf 07/27/2011 4:56 PM 510(k) Clearances > January 2007 510(k) Clearances 27 of 31 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/De... 71. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063151.pdf 72. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K061650.pdf 73. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062354.pdf 74. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063406.pdf 75. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062712.pdf 76. /cdrh/pdf6/K063192.pdf 77. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062892.pdf 78. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063785.pdf 79. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060272.pdf 80. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062868.pdf 81. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063290.pdf 82. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K061782.pdf 83. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062675.pdf 84. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063451.pdf 85. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063664.pdf 86. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063429.pdf 87. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063121.pdf 88. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063739.pdf 89. http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063589.pdf 90. 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