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Medical Devices
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August 2009 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD August 2009 DEVICE: S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 ALFA WASSERMANN, INC. 510(k) NO: K091333(TRADITIONAL)
ATTN: HYMAN KATZ PHONE NO : 973 852 0158 4 HENDERSON DR. SE DECISION MADE: 03-AUG-09 WEST CALDWELL NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES VISION-SCIENCES, INC. 510(k) NO: K091768(TRADITIONAL)
ATTN: LILLIAN QUINTERO PHONE NO : 845 365 0600 40 RAMLAND RD. SOUTH SE DECISION MADE: 03-AUG-09 ORANGEBURG NY 10962 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE ARTHREX, INC. 510(k) NO: K083707(TRADITIONAL)
ATTN: SALLY FOUST PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 03-AUG-09 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM STERIS CORPORATION 510(k) NO: K083097(TRADITIONAL)
ATTN: JOHN R SCOVILLE PHONE NO : 440 392 7330 5960 HEISLEY RD. SE DECISION MADE: 03-AUG-09 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUATTRO LT RESMED LTD. 510(k) NO: K091129(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858 746 2238 14040 DANIELSON ST. SE DECISION MADE: 03-AUG-09 POWAY CA 92064 6857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFECARE ELECTRODES EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K083302(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 678 908 8180 845 ARONSON LAKE COURT SE DECISION MADE: 03-AUG-09 ROSWELL GA 30075 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMSTAR AUTO A-FLEX RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K091319(TRADITIONAL)
ATTN: ZITA A YURKO PHONE NO : 724 387 4120 1001 MURRY RIDGE LN. SE DECISION MADE: 03-AUG-09 MURRYSVILLE PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732 C.R. BARD, INC. 510(k) NO: K091659(TRADITIONAL)
ATTN: GAIL DOW PHONE NO : 401 825 8582 100 CROSSINGS BLVD. SE DECISION MADE: 03-AUG-09 WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: DSS STABILIZATION SYSTEM PARADIGM SPINE, LLC 510(k) NO: K091944(SPECIAL)
ATTN: ADAM HERDER PHONE NO : 202 552 5800 1331 H STREET NW 12TH FLOOR SE DECISION MADE: 03-AUG-09 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESTORELLE POLYPROPYLENE MESH MPATHY MEDICAL DEVICES INC 510(k) NO: K092207(SPECIAL)
ATTN: CAROLINE STRETTON PHONE NO : 011 441 417736247 208 WRIGHT BUSINESS CENTRE LONMAY SE DECISION MADE: 04-AUG-09 GLASGOW UK G33-4EL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZC MEDICAL, LLC INTUBAIDFLEX EZC MEDICAL, LLC 510(k) NO: K090777(TRADITIONAL)
ATTN: PAVAN SETHI PHONE NO : 415 561 2550 16 A FUNSTON AVENUE SE DECISION MADE: 04-AUG-09 SAN FRANCISCO CA 94129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 GISH BIOMEDICAL, INC. 510(k) NO: K091062(TRADITIONAL)
ATTN: JANET PEETS PHONE NO : 949 635 6240 22942 ARROYO VISTA SE DECISION MADE: 04-AUG-09 RANCHO SANTA MARGARITA CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 RESTORATIVE THERAPIES INC. 510(k) NO: K090750(TRADITIONAL)
ATTN: ANDREW BARRISKILL PHONE NO : 800 609 9166 907 SOUTH LAKEWOOD AVE. SE DECISION MADE: 05-AUG-09 BALTIMORE MD 21224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NURSE'S ASSISTANT O.R. CONTROL SYSTEM ,1.8 CONMED INTEGRATED SYSTEMS (CMIS) 510(k) NO: K091648(TRADITIONAL)
ATTN: C. JEFF LIPPS PHONE NO : 503 614 1106 1815 NW 169TH PLACE SUITE 4020 SE DECISION MADE: 05-AUG-09 BEAVERTON OR 97006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM CARDO MEDICAL CORP. 510(k) NO: K091396(TRADITIONAL)
ATTN: DENISE DUCHENE PHONE NO : 973 777 8831 1033 US HIGHWAY 46E SE DECISION MADE: 05-AUG-09 CLIFTON NJ 07013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTILOCK PERIARTICULAR PLATING BIOMET TRAUMA 510(k) NO: K092078(SPECIAL)
ATTN: SHIKHA GOLA PHONE NO : 973 299 9300 100 INTERFACE PARKWAY SE DECISION MADE: 05-AUG-09 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE VIRAMED BIOTECH AG 510(k) NO: K082329(TRADITIONAL)
ATTN: BARRY E MENEFEE PHONE NO : 780 594 7285 1730 SOUTH DITMAR STREET SE DECISION MADE: 05-AUG-09 OCEANSIDE CA 92054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIPAP SYNCHRONY 2 RESPIRONICS, INC. 510(k) NO: K092043(SPECIAL)
ATTN: ZITA YURKO PHONE NO : 724 387 4120 1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 05-AUG-09 MONROEVILLE PA 15146 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 ABBOTT LABORATORIES INC 510(k) NO: K090358(TRADITIONAL)
ATTN: JUDI WALLACH PHONE NO : 847 937 1132 100 ABBOTT PARK ROAD AP6C-2; DEPT SE DECISION MADE: 06-AUG-09 ABBOTT PARK IL 60064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONTERIS MEDICAL UFO MONTERIS MEDICAL 510(k) NO: K090240(TRADITIONAL)
ATTN: CRAIG COOMBS PHONE NO : 650 380 2474 1193 SHERMAN STREET SE DECISION MADE: 06-AUG-09 ALAMEDA CA 94501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINI TIGHTROPE ARTHREX, INC. 510(k) NO: K090107(TRADITIONAL)
ATTN: SALLY FOUST PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 06-AUG-09 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM MEDTRONIC SOAFAMOR DANEK 510(k) NO: K091365(TRADITIONAL)
ATTN: MELISA LANSKY PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 06-AUG-09 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087 AMERICAN BIOLOGICAL TECHNOLOGIES, 510(k) NO: K091460(TRADITIONAL)
ATTN: JOHN GORMLEY PHONE NO : 830 372 1391 940 CROSSROADS BLVD. SE DECISION MADE: 06-AUG-09 SEGUIN TX 78155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K091289(TRADITIONAL)
ATTN: CLARE SANTULLI PHONE NO : 914 524 2701 511 BENEDICT AVENUE SE DECISION MADE: 06-AUG-09 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES SHINA CORP. 510(k) NO: K091167(TRADITIONAL)
ATTN: YONG NAM SHIN PHONE NO : 822 317 118180 # 1005, OWNER'S TOWER 16-5, SUNAE-SE DECISION MADE: 06-AUG-09 SEONGNAM-SI, GYEONGGI-DO KS 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND GE MEDICAL SYSTEMS ISRAEL, ULTRASO510(k) NO: K092079(SPECIAL)
ATTN: JAMES T TURNER PHONE NO : 262 544 3359 3000 N. GRANDVIEW BLVD. SE DECISION MADE: 06-AUG-09 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEYONDIMAGE WORKSTATION NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K092235(TRADITIONAL)
ATTN: TIAN YUEHUI PHONE NO : 862 483 660646 NO. 16, SHIJI ROAD HUNNAN INDUSRTISE DECISION MADE: 06-AUG-09 SHENYANG, LIAONING CH 110179 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 BIOSENSE WEBSTER, INC. 510(k) NO: K092064(SPECIAL)
ATTN: MELISSA SCHULTZ PHONE NO : 909 839 8787 3333 DIAMOND CANYON RD. SE DECISION MADE: 07-AUG-09 DIAMOND BAR CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) EUROIMMUN US INC 510(k) NO: K083053(TRADITIONAL)
ATTN: KATHRYN KOHL PHONE NO : 973 270 0912 95 WASHINGTON ST SE DECISION MADE: 07-AUG-09 MORRISTOWN NJ 07960 510(k) STATEMENT DEVICE: BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (GS-OP-R), REUSABLE HANDPIECE CABLE (GS807-RC) BOVIE MEDICAL 510(k) NO: K090586(TRADITIONAL)
ATTN: RICHARD A KOZLOFF PHONE NO : 727 803 8513 5115 ULMERTON ROAD SE DECISION MADE: 07-AUG-09 CLEARWATER FL 33760 4004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIFY 275F GRAVITY INDICATORS STERIS CORPORATION 510(k) NO: K083643(ABBREVIATED)
ATTN: JOHN ROBERT SCOVILLE, JR. PHONE NO : 440 392 7330 5960 HEISLEY RD. SE DECISION MADE: 07-AUG-09 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECOCEL POLICHEM S.A. 510(k) NO: K083087(TRADITIONAL)
ATTN: HARI NAGARADONA PHONE NO : 301 838 3120 7361 CALHOUN PLACE SUITE 500 SE DECISION MADE: 07-AUG-09 ROCKVILLE MD 20855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT WEIHAI JIERUI MEDICAL PRODUCTS CO.510(k) NO: K083429(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 216 4264467 STE 8D, NO.19, LANE 999 ZHONGSHAN SE DECISION MADE: 07-AUG-09 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KOWA, FM-600, MODEL LSS50 KOWA CO. LTD. 510(k) NO: K091039(TRADITIONAL)
ATTN: SATOHIKO TAKANASHI PHONE NO : 813 562 38063 4-14, NIHONBASHI-HONCHO 3-CHOME SE DECISION MADE: 07-AUG-09 CHUO-KU, TOKYO JA 103-8433 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET C.R. BARD, INC. 510(k) NO: K091324(TRADITIONAL)
ATTN: RICK GAYKOWSKI PHONE NO : 801 522 5432 605 NORTH 5600 WEST SE DECISION MADE: 07-AUG-09 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KOWAGENESIS-DF KOWA CO. LTD. 510(k) NO: K091098(TRADITIONAL)
ATTN: AKIHIRO GUJITA PHONE NO : 813 562 38049 4-14, NIHONBASHI-HONCHO 3-CHOME SE DECISION MADE: 07-AUG-09 CHUO-KU, TOKYO JA 103-8433 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IBEX SPINAL SYSTEM EBI, L.P. 510(k) NO: K091381(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 973 299 9300 100 INTERPACE PKWY. SE DECISION MADE: 07-AUG-09 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K091041(TRADITIONAL)
ATTN: ZHENG LIU PHONE NO : 508 977 3966 325 PARAMOUNT DR. SE DECISION MADE: 07-AUG-09 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A AMCO INTERNATIONAL MANUFACTURING &510(k) NO: K091548(TRADITIONAL)
ATTN: ALEXANDER B HENDERSON PHONE NO : 303 646 3715 377 ZANE COURT SE DECISION MADE: 07-AUG-09 ELIZABETH CO 80107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHARMAPAC PERSONAL LUBRICANT PHARMAPAC LLC 510(k) NO: K091554(TRADITIONAL)
ATTN: TOM OTTO PHONE NO : 601 743 9771 110 INDUSTRIAL PARK ROAD SE DECISION MADE: 07-AUG-09 DEKALB MS 39329 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 ISORAY MEDICAL, INC. 510(k) NO: K092136(SPECIAL)
ATTN: FRED SWINDLER PHONE NO : 509 375 1202 350 HILLS ST., SUITE 106 SE DECISION MADE: 07-AUG-09 RICHLAND WA 99354 5411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH CRYOLIFE, INC. 510(k) NO: K091626(TRADITIONAL)
ATTN: JOHN FERROS PHONE NO : 770 419 3355 1655 ROBERTS BLVD., N.W. SE DECISION MADE: 07-AUG-09 KENNESAW GA 30144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEPHAFLEX SURGICAL FILM TEPHA, INC. 510(k) NO: K091633(TRADITIONAL)
ATTN: MARY P LEGRAW PHONE NO : 781 357 1700 99 HAYDEN, SUTIE 360 SE DECISION MADE: 07-AUG-09 LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CDB FLIP-SIDE-CLIP BRACKET CDB CORPORATION 510(k) NO: K091702(TRADITIONAL)
ATTN: CHARLES VERNON PHONE NO : 910 383 6464 9201 INDUSTRIAL BLVD. SE DECISION MADE: 07-AUG-09 LELAND NC 28451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APPROACH HYDRO ST WIRE GUIDE, MODEL HMW COOK, INC. 510(k) NO: K091385(SPECIAL)
ATTN: KAREN BRADBURN PHONE NO : 812 339 2235 750 DANIELS WAY PO BX 489 SE DECISION MADE: 07-AUG-09 BLOOMINGTON IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUJINON STERILE OVERTUBES FUJINON, INC. 510(k) NO: K091773(SPECIAL)
ATTN: JOSEPH M AZARY PHONE NO : 203 922 0105 80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 07-AUG-09 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HORIZON XVU MENNEN MEDICAL LTD. 510(k) NO: K091165(TRADITIONAL)
ATTN: IFAT OREN PHONE NO : 972 893 23333 4 HAYARDEN ST., YAVNE P.O.BOX 102 SE DECISION MADE: 07-AUG-09 REHOVOT IS 76100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES CONMED CORPORATION 510(k) NO: K091856(SPECIAL)
ATTN: SANDRA COVELESKI PHONE NO : 315 624 3435 525 FRENCH RD. SE DECISION MADE: 07-AUG-09 UTICA NY 13502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5% CENTURY PHARMACEUTICALS, INC. 510(k) NO: K090791(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 07-AUG-09 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EN SNARE ENDOVASCULAR SNARE SYSTEM MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K092343(TRADITIONAL)
ATTN: GLENN NORTON PHONE NO : 801 208 4795 1600 WEST MERIT PKWY. SE DECISION MADE: 07-AUG-09 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 ST. JUDE MEDICAL, CARDIAC RHYTHM M510(k) NO: K092075(SPECIAL)
ATTN: COLLEEN CANAN PHONE NO : 818 493 2960 15900 VALLEY VIEW CT. SE DECISION MADE: 07-AUG-09 SYLMAR CA 91342 510(k) STATEMENT DEVICE: SIGNAL ZARGIS MEDICAL CORP. 510(k) NO: K090493(TRADITIONAL)
ATTN: JOHN KALLASSY PHONE NO : 888 773 3669 2 RESEARCH WAY, 1ST FLOOR SE DECISION MADE: 07-AUG-09 PRINCETON NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONOPOLY PEDICLE SCREW SYSTEM SIGNUS MEDICAL 510(k) NO: K092073(SPECIAL)
ATTN: THOMAS HOGHAUG PHONE NO : 952 294 8700 188888 LAKE DRIVE EAST SE DECISION MADE: 07-AUG-09 CHANHASSEN MN 55317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A BAXTER HEALTHCARE CORP. 510(k) NO: K090002(TRADITIONAL)
ATTN: DONNA DJINOVICH PHONE NO : 847 473 6896 1620 WAUKEGAN ROAD, MPGR-AL SE DECISION MADE: 07-AUG-09 MCGAW PARK IL 60085 6730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRAILBLAZER SUPPORT CATHETER EV3 INC 510(k) NO: K092299(TRADITIONAL)
ATTN: DAVID ROBERTSON PHONE NO : 763 398 7738 1394 25TH STREET NW SE DECISION MADE: 07-AUG-09 BUFFALO MN 55113 2920 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LAGUNA SIZE 8 PEDICLE SCREW SYSTEM ALLEZ SPINE, LLC 510(k) NO: K091995(SPECIAL)
ATTN: HARTMUT LOCH PHONE NO : 949 752 7885 2301 DUPONT DRIVE, SUITE 510 SE DECISION MADE: 07-AUG-09 IRVINE CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GDX VCC WITH ECC SOFTWARE CARL ZEISS MEDITEC INC. 510(k) NO: K082016(TRADITIONAL)
ATTN: JUDITH A BRIMACOMBE PHONE NO : 925 557 4616 5160 HACIENDA DRIVE SE DECISION MADE: 10-AUG-09 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONIC AIR MM1500 + (MID), MODEL 50400014 MICRO-MEGA SOCIETE ANONYME 510(k) NO: K081268(TRADITIONAL)
ATTN: ISABELLE BOURG PHONE NO : 333 81 544229 5-12 RUE DU TUNNEL SE DECISION MADE: 10-AUG-09 CEDEX BESANCON FR 25006 510(k) STATEMENT DEVICE: SCALAR WAVE LASER SYSTEM STELLAR LASERS 510(k) NO: K091158(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720 962 5412 5401 S. COTTONWOOD CT. SE DECISION MADE: 10-AUG-09 GREENWOOD VILLAGE CO 80121 510(k) STATEMENT DEVICE: UC-CARE WARMING SYSTEM UC-CARE LTD. 510(k) NO: K090978(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202 637 5794 555 THIRTEENTH STREET NW COLUMBIA SE DECISION MADE: 10-AUG-09 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP MASIMO CORPORATION 510(k) NO: K090662(TRADITIONAL)
ATTN: MARGUERITE THOMLINSON PHONE NO : 949 297 7000 40 PARKER SE DECISION MADE: 10-AUG-09 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 KIMBERLY-CLARK CORP. 510(k) NO: K091357(ABBREVIATED)
ATTN: DAVID M LEE PHONE NO : 770 587 7167 1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 10-AUG-09 ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCELL EVO3C ISOTIS ORTHOBIOLOGICS, INC 510(k) NO: K091193(TRADITIONAL)
ATTN: CARROLL COUNCILMAN PHONE NO : 858 271 6330 2 GOODYEAR, SUITE A SE DECISION MADE: 10-AUG-09 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERED VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG CENTURY PLASTIC CO., 510(k) NO: K091521(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 RM 1606 BLDG.1 JIANXIZNG YUAN, NO.SE DECISION MADE: 10-AUG-09 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMSURE HYDROPHILIC LATEX FOLEY CATHETER AMSINO INTERNATIONAL, INC. 510(k) NO: K091699(SPECIAL)
ATTN: JESUS FARINAS PHONE NO : 909 626 5888 855 TOWNE CENTER DR. SE DECISION MADE: 10-AUG-09 POMONA CA 91767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOOM-100DC BRAINSCOPE COMPANY, INC. 510(k) NO: K082886(TRADITIONAL)
ATTN: MICHAEL E SINGER PHONE NO : 202 776 1466 1717 RHODE ISLAND AVE. 9TH FLOOR SE DECISION MADE: 10-AUG-09 WASHINGTON DC 20036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JIAJIAN ACUPUNCTURE NEEDLE WUXI JIAJIAN MEDICAL INSTRUMENT CO510(k) NO: K090199(TRADITIONAL)
ATTN: DORIS DONG PHONE NO : 86 510 88745788 QINGHONG RD., EHU TOWN XISHAN DISTSE DECISION MADE: 11-AUG-09 WUXI, JIANGSU CH 214116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400 SOPHYSA SA 510(k) NO: K090342(TRADITIONAL)
ATTN: ESTHER SALTZ PHONE NO : 949 463 8083 2884 DANAPOPLAR SE DECISION MADE: 11-AUG-09 DANA POINT CA 92629 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, SPES MEDICA S.R.L. 510(k) NO: K091410(TRADITIONAL)
ATTN: ALFREDO SPADAVECCHIA PHONE NO : 390 828 614191 VIA EUROPA-ZONA INDUSTRIALE SE DECISION MADE: 11-AUG-09 BATTIPAGLIA IT 84091 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTEUS 235 PROTON THERAPY SYSTEM ION BEAM APPLICATIONS S.A. 510(k) NO: K091629(TRADITIONAL)
ATTN: YVES JONGEN PHONE NO : 32 10 475890 3 CHEMIN DU CYCLOTRON SE DECISION MADE: 11-AUG-09 LOUVAIN-LA-NEUVE, BE BE 1348 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: SENTINEL SPINAL SYSTEM LIFE SPINE 510(k) NO: K090343(TRADITIONAL)
ATTN: MURALI AUDIPUDY PHONE NO : 847 884 6117 2401 W. HASSELL RD. SUITE 1535 SE DECISION MADE: 11-AUG-09 HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS AGFA HEALTHCARE N.V. 510(k) NO: K092238(TRADITIONAL)
ATTN: JEFFERY A JEDLICKA PHONE NO : 864 421 1815 SEPTESTRAAT 27 SE DECISION MADE: 11-AUG-09 MORTSEL BE B 2640 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SWITCH TRT AUDIFON GMBH & CO. KG 510(k) NO: K091552(ABBREVIATED)
ATTN: JANE PERRONE PHONE NO : 800 776 0222 403 CHAIRMAN CT. SUITE 1 SE DECISION MADE: 12-AUG-09 DEBARY FL 32713 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOOTPRINT URINARY DRAINAGE CATHETER FOOTPRINT MEDICAL 510(k) NO: K090576(TRADITIONAL)
ATTN: CLYDE BAKER PHONE NO : 210 226 2600 1203 CAMDEN ST. SE DECISION MADE: 12-AUG-09 SAN ANTONIO TX 78215 510(k) STATEMENT DEVICE: INVISION SYSTEM INNEROPTIC TECHNOLOGY, INC 510(k) NO: K083728(TRADITIONAL)
ATTN: CAROLINE GREEN PHONE NO : 919 732 2090 106-A N CHURTON ST SE DECISION MADE: 12-AUG-09 HILLSBOROUGH NC 27278 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) TANGSHAN ZHONGPU PLASTIC PRODUCTS 510(k) NO: K090551(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606 BLDG 1, JIANXIANG YUAN NSE DECISION MADE: 12-AUG-09 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HDR PROSTATE TEMPLATE AND ACCESSORIES PHOTON TECHNOLOGIES CORPORATION 510(k) NO: K091230(TRADITIONAL)
ATTN: JEFFREY A EDWARDS PHONE NO : 770 716 9958 1572 N. HIGHWAY 85, STE. 308 SE DECISION MADE: 12-AUG-09 FAYETTEVILLE GA 30214 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 DEPUY ORTHOPAEDICS, INC. 510(k) NO: K091453(TRADITIONAL)
ATTN: SUZANA OTANO PHONE NO : 305 269 6386 700 ORTHOPAEDIC DR. SE DECISION MADE: 12-AUG-09 WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIPRO DISPOSABLE SYRINGE NIPRO MEDICAL CORPORATION 510(k) NO: K091279(SPECIAL)
ATTN: JESSICA OSWALD PHONE NO : 305 599 7174 3150 N.W. 107TH AVE. SE DECISION MADE: 12-AUG-09 MIAMI FL 33172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TANSCU O2 ELECTROCHEMICAL OXYGEN CONCEPTS, I510(k) NO: K090681(ABBREVIATED)
ATTN: CARL JENKINS PHONE NO : 847 234 7500 10 E SCRANTON AVE SUITE 201 SE DECISION MADE: 12-AUG-09 LAKE BLUFF IL 60044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR SORIN GROUP ITALIA S.R.L. 510(k) NO: K092315(SPECIAL)
ATTN: BARRY SAIL PHONE NO : 781 434 4742 200 WEST STREET SE DECISION MADE: 12-AUG-09 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIXPLORERE, MODEL P90001-01A SUPERSONIC IMAGINE 510(k) NO: K091970(TRADITIONAL)
ATTN: JACQUES SOUQUET PHONE NO : 334 429 92435 510 RUE RENE DESCARTES SE DECISION MADE: 12-AUG-09 AIX-EN-PROVENCE FR 13857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST BINAX, INC. 510(k) NO: K092223(SPECIAL)
ATTN: ANGELA DRYSDALE PHONE NO : 207 730 5737 10 SOUTHGATE RD. SE DECISION MADE: 12-AUG-09 SCARBOROUGH ME 04074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNISURE URETHRAL SLING, MODEL OTK52 MPATHY MEDICAL DEVICES, LTD. 510(k) NO: K092203(SPECIAL)
ATTN: CAROLINE STRETTON PHONE NO : 011 441 417736244 LONMAY ROAD SE DECISION MADE: 12-AUG-09 GLASGOW UK G33 4EL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ IMPACT INSTRUMENTATION, INC. 510(k) NO: K091238(TRADITIONAL)
ATTN: LESLIE H SHERMAN PHONE NO : 973 882 1212 27 FAIRFIELD PL. SE DECISION MADE: 13-AUG-09 WEST CALDWELL NJ 07006 0508 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANOVA CONTAINMENT DEVICE ANOVA CORPORATION 510(k) NO: K063461(TRADITIONAL)
ATTN: CAMPBELL TUSKEY PHONE NO : 202 822 1850 2001 PENNSYLVANIA AVE., NW SE DECISION MADE: 13-AUG-09 WASHINGTON DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE GYRUS ACMI, INC. 510(k) NO: K080844(TRADITIONAL)
ATTN: LORRAINE CALZETTA PHONE NO : 508 804 2752 136 TURNPIKE RD. SE DECISION MADE: 13-AUG-09 SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR PURNABINA SDN BHD 510(k) NO: K083571(TRADITIONAL)
ATTN: ROBERT HILL PHONE NO : 09 774 7171 1A JALAN 8 PENGKALAN CHEPA 2 IND ZSE DECISION MADE: 13-AUG-09 KLUANG, JOHOR MY 86007 510(k) STATEMENT DEVICE: TROPAZONE LOTION MIDLOTHIAN LABORATORIES 510(k) NO: K090337(TRADITIONAL)
ATTN: BRYCE HARVEY PHONE NO : 334 288 8661 760 INDUSTRIAL PARK BLVD. UNIT C SE DECISION MADE: 13-AUG-09 MONTGOMERY AL 36117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHROMA, MODEL: RZ153C SCOTTCARE CORPORATION 510(k) NO: K083382(TRADITIONAL)
ATTN: TIMOTHY J LEYVA PHONE NO : 216 362 0550 4791 WEST 150TH ST. SE DECISION MADE: 13-AUG-09 CLEVELAND OH 44135 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TT-102 TISSUE TECHNOLOGIES HOLDINGS, LLC 510(k) NO: K081246(TRADITIONAL)
ATTN: YOUSEF MOHAJER PHONE NO : 804 225 7447 800 EAST LEIGH ST., SUITE 51 SE DECISION MADE: 13-AUG-09 RICHMOND VA 23219 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMM DENTAL IRRIGATION TUBING SET INNOVATIVE MEDICAL MANUFACTURING C510(k) NO: K090727(TRADITIONAL)
ATTN: JOSEPH J CHANG PHONE NO : 832 545 8399 7128 STAFFORDSHIRE ST. SE DECISION MADE: 13-AUG-09 HOUSTON TX 77030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HELIO2 BLENDER PRECISION MEDICAL, INC. 510(k) NO: K090781(TRADITIONAL)
ATTN: JAMES PARKER PHONE NO : 610 262 6090 300 HELD DR. SE DECISION MADE: 13-AUG-09 NORTHAMPTON PA 18067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOXQ 980 LASER A.R.C. LASER GMBH 510(k) NO: K091059(TRADITIONAL)
ATTN: KIRSTEN PAULSON PHONE NO : 301 795 2639 3202 TOWER OAKS BLVD SUITE 300 SE DECISION MADE: 13-AUG-09 ROCKVILLE MD 20852 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVERE 6.35 STABILIZATION SYSTEM GLOBUS MEDICAL INC. 510(k) NO: K091782(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610 415 9000 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 13-AUG-09 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHTLAS SELECTOR LIGHTMED CORP. 510(k) NO: K090774(TRADITIONAL)
ATTN: ANITA CHEN PHONE NO : 886 268 81726 NO.1-1, LANE1,PAO-AN ST. SEC.3 SE DECISION MADE: 13-AUG-09 SHULIN CITY TW 238 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUSS THORACOLUMBAR PLATE SYSTEM GLOBUS MEDICAL, INC. 510(k) NO: K092108(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610 415 9000 2560 GENERAL ARMISTEAD AVE. VALLEYSE DECISION MADE: 13-AUG-09 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALMA LASERS ALEX755 MODULE ALMA LASERS LTD. 510(k) NO: K090571(TRADITIONAL)
ATTN: HOWARD KELLY PHONE NO : 925 895 1200 485 HALF DAY ROAD SUITE 100 SE DECISION MADE: 13-AUG-09 BUFFALO GROVE IL 60089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 INSTRATEK, INC. 510(k) NO: K091763(SPECIAL)
ATTN: JEFF SEAVEY PHONE NO : 281 890 8020 210 SPRINGHILL DR. SUITE 130 SE DECISION MADE: 14-AUG-09 SPRING TX 77386 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 BECKMAN COULTER, INC. 510(k) NO: K091742(TRADITIONAL)
ATTN: MARINE BOYAJIAN PHONE NO : 714 961 6536 200 S. KRAEMER BLVD. M/S W-110 SE DECISION MADE: 14-AUG-09 BREA CA 92822 8000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCANSCOPE XT SYSTEM APERIO TECHNOLOGIES 510(k) NO: K080564(TRADITIONAL)
ATTN: JEFF RYBERG PHONE NO : 760 539 1114 1360 PARK CENTER DR SE DECISION MADE: 14-AUG-09 VISTA CA 92081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LENSX 550 LASER SYSTEM LENSX LASERS, INC. 510(k) NO: K082947(TRADITIONAL)
ATTN: JUDY GORDON PHONE NO : 949 715 0609 733 BOLSANA DR. SE DECISION MADE: 14-AUG-09 LAGUNA BEACH CA 92651 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS THE ELECTRODE STORE, INC. 510(k) NO: K083758(TRADITIONAL)
ATTN: CARL YOUNGMANN PHONE NO : 360 379 3660 1530 HOLCOMB STREET SE DECISION MADE: 14-AUG-09 PORT TOWNSEND WA 98368 510(k) STATEMENT DEVICE: ASFORA BULLET CAGE SYSTEM MEDICAL DESIGNS, LLC 510(k) NO: K090048(TRADITIONAL)
ATTN: KRISTI VONDRA PHONE NO : 605 275 1032 1210 W. 18TH ST. NORTH CENTER, SUISE DECISION MADE: 14-AUG-09 SIOUX FALLS SD 57104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K090740(SPECIAL)
ATTN: LILA JOE PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 14-AUG-09 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 ARKRAY FACTORY USA, INC. 510(k) NO: K090332(TRADITIONAL)
ATTN: HAMID IDRISSI PHONE NO : 952 646 3171 5182 WEST 76TH ST. SE DECISION MADE: 14-AUG-09 MINNEAPOLIS MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL DIAZYME LABORATORIES 510(k) NO: K091455(TRADITIONAL)
ATTN: ABHIJIT DATTA PHONE NO : 858 455 4762 12889 GREGG COURT SE DECISION MADE: 14-AUG-09 POWAY CA 92064 510(k) STATEMENT DEVICE: ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K091123(ABBREVIATED)
ATTN: CLARE SANTULLI PHONE NO : 914 524 2701 511 BENEDICT AVENUE SE DECISION MADE: 14-AUG-09 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 GRAM NEGATIVE MEROPENEM BIOMERIEUX, INC. 510(k) NO: K091899(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314 731 8695 595 ANGLUM RD. SE DECISION MADE: 14-AUG-09 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET B. BRAUN MEDICAL, INC. 510(k) NO: K090995(TRADITIONAL)
ATTN: LISA GIAQUINTO PHONE NO : 610 596 2354 901 MARCON BLVD. SE DECISION MADE: 14-AUG-09 ALLENTOWN PA 18109 9341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE CARDIOPULMONARY CORP. 510(k) NO: K091461(TRADITIONAL)
ATTN: JORDAN SCHRECK PHONE NO : 203 877 1999 200 CASCADE BLVD. SE DECISION MADE: 14-AUG-09 MILFORD CT 06460 510(k) STATEMENT DEVICE: MEDI-6000 MEDICAL IMAGE DIGITIZER MICROTEK INTERNATIONAL, INC. 510(k) NO: K091288(TRADITIONAL)
ATTN: HUI-CHEN KAI PHONE NO : 886 3 3280026 NO. 8, LANE 29 WENMING ROAD SE DECISION MADE: 14-AUG-09 GUISAN, TAOYUAN TW 33383 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATHFAST CK-MM-II, PATHFAST MYO-II MITSUBISHI KAGAKU IATRON 510(k) NO: K081360(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 206 262 7364 701 FIFTH AVENUE FLOOR 42 SE DECISION MADE: 17-AUG-09 SEATTLE WA 98104 510(k) STATEMENT DEVICE: SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 GARRISON DENTAL SOLUTIONS 510(k) NO: K091533(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203 922 0105 80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 17-AUG-09 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE CUSTOM SPINE, INC. 510(k) NO: K091134(TRADITIONAL)
ATTN: SAAD ATTIYAH PHONE NO : 973 265 5036 1140 PARSIPPANY BLVD. SUITE 201 SE DECISION MADE: 17-AUG-09 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TISSU TRANS HARVEST TUBING SHIPPERT MEDICAL TECHNOLOGIES CORP510(k) NO: K092022(SPECIAL) ATTN: SARAH L SHIPPERT PHONE NO : 303 754 0044 6248 SOUTH TROY CIRCLE UNIT A SE DECISION MADE: 17-AUG-09 CENTENNIAL CO 80111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES ENCISION, INC. 510(k) NO: K091074(TRADITIONAL)
ATTN: JUDITH KING PHONE NO : 303 444 2600 6797 WINCHESTER CIR. SE DECISION MADE: 17-AUG-09 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL BIOMET TRAUMA 510(k) NO: K091976(TRADITIONAL)
ATTN: MARGARET CROWE PHONE NO : 973 299 9300 100 INTERPACE PARKWAY SE DECISION MADE: 17-AUG-09 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S. AUREUS PNA FISH ADVANDX, INC. 510(k) NO: K091827(TRADITIONAL)
ATTN: PAULA E BURGER PHONE NO : 339 227 4072 10A ROESSLER ROAD SE DECISION MADE: 18-AUG-09 WOBURN MA 01801 510(k) STATEMENT DEVICE: DISPOSABLE PRESSURE TRANSDUCER SHENZHEN ANT HI-TECH INDUSTRIAL CO510(k) NO: K091408(TRADITIONAL)
ATTN: LEE FU PHONE NO : 86 21 64684973 SUITE 8D, ZHONGXIN ZHONGSHAN NO.19SE DECISION MADE: 18-AUG-09 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT SMITHS MEDICAL ASD, INC. 510(k) NO: K083031(TRADITIONAL)
ATTN: JOHN TULLETT PHONE NO : 44 130 3260551 BOUNDARY ROAD SE DECISION MADE: 18-AUG-09 HYTHE, KENT UK CT216JN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS AA NEUROMED CORP. 510(k) NO: K083250(TRADITIONAL)
ATTN: HERMANN DOLKER PHONE NO : 604 941 0551 1911 RODGER AVENUE SE DECISION MADE: 18-AUG-09 PORT COQUITLAM, BC CA V3C 1B8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRA FLUORESCENCE CARIES DETECTION DEVICE AIR TECHNIQUES, INC. 510(k) NO: K090169(TRADITIONAL)
ATTN: NATALYA VALERIO PHONE NO : 516 482 9001 55 NORTHERN BLVD SUITE 200 SE DECISION MADE: 18-AUG-09 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. 510(k) NO: K091481(SPECIAL)
ATTN: Y.C. LEI PHONE NO : 886 3 5752522 2 F,NO.49-2, LANE 2, SEC. 2, GUANGSE DECISION MADE: 18-AUG-09 HSINCHU CITY TW 300 510(k) STATEMENT DEVICE: SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD ANDON HEALTH CO.,LTD 510(k) NO: K091738(SPECIAL)
ATTN: LIU YI PHONE NO : 862 260 526161 NO 31, CHANGJIANG ROAD NANKAI DISTSE DECISION MADE: 18-AUG-09 TIANJIN CH 300193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909 ANDON HEALTH CO.,LTD 510(k) NO: K091739(SPECIAL)
ATTN: LIU YI PHONE NO : 862 260 5261618060 NO 31, CHANGJIANG ROAD NANKAI DISTSE DECISION MADE: 18-AUG-09 TIANJIN CH 300193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KODAK 1500 INTRAORAL CAMERA CARESTREAM HEALTH, INC. 510(k) NO: K091186(TRADITIONAL)
ATTN: DANIEL HOEFER PHONE NO : 770 226 3287 1765 THE EXCHANGE SE DECISION MADE: 18-AUG-09 ATLANTA GA 30339 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031 ANDON HEALTH CO.,LTD 510(k) NO: K091737(SPECIAL)
ATTN: LIU YI PHONE NO : 86 226 0526161 NO 31, CHANGJIANG ROAD NANKAI DISTSE DECISION MADE: 18-AUG-09 TIANJIN CH 300193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K090818(TRADITIONAL)
ATTN: MONIKA CAMPBELL PHONE NO : 310 338 8100 2151 E. GRAND AVE. SE DECISION MADE: 18-AUG-09 EL SEGUNDO CA 90245 510(k) STATEMENT DEVICE: ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS ROCHE DIAGNOSTICS 510(k) NO: K082699(TRADITIONAL)
ATTN: JANE PHILLIPS PHONE NO : 317 521 3338 9115 HAGUE RD. SE DECISION MADE: 19-AUG-09 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRA SP II, SPECTRA DENTA II LUTRONIC CORPORATION 510(k) NO: K091320(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978 207 1245 5 TIMBER LANE SE DECISION MADE: 19-AUG-09 NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTURA CAVITY MAINTENANCE CATHETER SENORX, INC. 510(k) NO: K092323(TRADITIONAL)
ATTN: EBEN GORDON PHONE NO : 949 362 4800 3 MORGAN SE DECISION MADE: 19-AUG-09 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: K-LASER K-1200, MODEL 12 W ELTECH, S.R.L. 510(k) NO: K091497(TRADITIONAL)
ATTN: RICHARD ALBRIGHT PHONE NO : 866 595 7749 311 S. ROYAL OAKS BLVD. SUITE 140-SE DECISION MADE: 19-AUG-09 FRANKLIN TN 37064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014 PURICORE INC. 510(k) NO: K092232(SPECIAL)
ATTN: DENNIS J MAHONEY PHONE NO : 484 321 2724 508 LAPP RD. SE DECISION MADE: 19-AUG-09 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERUMO PALL AL3X ARTERIAL FILTER TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K083747(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800 283 7866 125 BLUE BALL RD. SE DECISION MADE: 20-AUG-09 ELKTON MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP MK BIO, INC 510(k) NO: K082977(SPECIAL)
ATTN: JANE ZHANG PHONE NO : 858 875 1956 10239 FLANDERS CT SE DECISION MADE: 20-AUG-09 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, HOLLISTER, INC. 510(k) NO: K090960(TRADITIONAL)
ATTN: CHRIS STUKEL PHONE NO : 847 918 3452 2000 HOLLISTER DR. SE DECISION MADE: 20-AUG-09 LIBERTYVILLE IL 60048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TUTTNAUER ELARA-11" PRE-VACUUM TABLETOP AUTOCLAVE TUTTNAUER USA CO. LTD. 510(k) NO: K090783(TRADITIONAL)
ATTN: THEODORE SULLIVAN PHONE NO : 202 452 7992 1700 K STREET, NW SUITE 300 SE DECISION MADE: 20-AUG-09 WASHINGTON DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERCURY CPAP MERCURY MEDICAL 510(k) NO: K090710(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 20-AUG-09 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CABLE, TRANSDUCER, MODEL 2400GN CONMED CORPORATION 510(k) NO: K083448(TRADITIONAL)
ATTN: SARAH RIZK PHONE NO : 315 624 3219 525 FRENCH RD. SE DECISION MADE: 20-AUG-09 UTICA NY 13502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LSVT C OR LSVT COMPANION, MODEL V.1 LSVT GLOBAL, LLC 510(k) NO: K091682(TRADITIONAL)
ATTN: DAVID H MCFARLAND PHONE NO : 888 438 5788 6900 E SUNRISE DRIVE SUITE 120 #24SE DECISION MADE: 20-AUG-09 TUCSON AZ 85750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH HANDPIECE HEADQUARTERS 510(k) NO: K092053(TRADITIONAL)
ATTN: TIM ROPCHAN PHONE NO : 714 579 0175 620 S. PLACENTIA AVE. SE DECISION MADE: 20-AUG-09 PLACENTIA CA 92870 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO PROFLU+ ASSAY PRODESSE, INC. 510(k) NO: K092500(SPECIAL)
ATTN: KRISTINE SCHRAUFNAGEL PHONE NO : 262 446 0700 W229N1870 WESTWOOD DR. SE DECISION MADE: 20-AUG-09 WAUKESHA WI 53186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMAPULSE PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K092222(SPECIAL)
ATTN: SHARON TIMBERLAKE PHONE NO : 781 993 2414 82 CAMBRIDGE ST. SE DECISION MADE: 20-AUG-09 BURLINGTON MA 01803 510(k) STATEMENT DEVICE: ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K092201(SPECIAL)
ATTN: SARAH FAIRFIELD PHONE NO : 901 290 5812 5677 AIRLINE RD. SE DECISION MADE: 20-AUG-09 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XTRACT SYRINGE KEYS XTRACT SOLUTIONS, LLC 510(k) NO: K091200(TRADITIONAL)
ATTN: KEITH LOWREY PHONE NO : 541 476 1628 611 SOUTH SCHOOLHOUSE CREEK RD SE DECISION MADE: 21-AUG-09 GRANTS PASS OR 97526 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TANTALUM BEAD SET, MODEL P003175 HALIFAX BIOMEDICAL, INC. 510(k) NO: K090581(TRADITIONAL)
ATTN: ROSHANA AHMED PHONE NO : 905 689 3980 4 INNOVATION DR. SE DECISION MADE: 21-AUG-09 DUNDAS, ONTARIO CA L9H 7P3 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX PROTEC GMBH & CO. KG 510(k) NO: K091628(TRADITIONAL)
ATTN: JOCHEN KRUPP PHONE NO : 49 706 2925520 LICHTENBERGER STR. 35 SE DECISION MADE: 21-AUG-09 OBERSTENFELD GM 71720 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) CAS MEDICAL SYSTEMS, INC. 510(k) NO: K091452(TRADITIONAL)
ATTN: RON JEFFREY PHONE NO : 203 488 6056 44 EAST INDUSTRIAL RD. SE DECISION MADE: 21-AUG-09 BRANFORD CT 06405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARE PAL, MODEL CPW-10X DIGIO2 INTERNATIONAL CO., LTD 510(k) NO: K091430(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928 773 9488 2904 N BOLDT DRIVE SE DECISION MADE: 21-AUG-09 FLAGSTAFF AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEAN PEAK FLOW METER VIASYS HEALTHCARE GMBH 510(k) NO: K091412(SPECIAL)
ATTN: THOMAS RUST PHONE NO : 499 314 972383 LEIBNIZSTRASSE 7 SE DECISION MADE: 21-AUG-09 HOECHBERG GM 97204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYOSURE ROD LENS HYSTEROSCOPE INTERLACE MEDICAL, INC. 510(k) NO: K091465(TRADITIONAL)
ATTN: JOHN VOZELLA PHONE NO : 508 875 1343 135 NEWBURY STREET SE DECISION MADE: 21-AUG-09 FRAMINGHAM MA 01701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMSURE PVC INTERMITTENT CATHETER AMSINO INTERNATIONAL, INC. 510(k) NO: K091306(SPECIAL)
ATTN: HOLIVEN JI PHONE NO : 909 626 5888 855 TOWNE CENTER DR. SE DECISION MADE: 21-AUG-09 POMONA CA 91767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SKINTACT AND VARIOUS OTHER TRADENAMES LEONHARD LANG GMBH 510(k) NO: K092291(SPECIAL)
ATTN: ELAINE DUNCAN PHONE NO : 715 549 6035 P.O. BOX 560 SE DECISION MADE: 21-AUG-09 STILLWATER MN 55082 0560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND GE MEDICAL SYSTEMS ISRAEL, ULTRASO510(k) NO: K092140(SPECIAL)
ATTN: JAMES TURNER PHONE NO : 262 544 3359 3000 N. GRANDVIEW BLVD. SE DECISION MADE: 21-AUG-09 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484 INVIVO 510(k) NO: K091902(TRADITIONAL)
ATTN: ELIZABETH WHEELER PHONE NO : 352 336 0010 3545 S.W. 47TH AVE. SE DECISION MADE: 21-AUG-09 GAINESVILLE FL 32608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERCURY VCO2 RESPIRONICS NOVAMETRIX, INC. 510(k) NO: K092217(SPECIAL)
ATTN: KEVIN MADER PHONE NO : 203 697 6466 5 TECHNOLOGY DR. SE DECISION MADE: 21-AUG-09 WALLINGFORD CT 06492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIRECTVISION GUIDE SYSTEM PERCUVISION LLC 510(k) NO: K091600(TRADITIONAL)
ATTN: ERROL O SINGH, M.D. PHONE NO : 614 337 8700 765 NORTH HAMILTON RD. SUITE 260A SE DECISION MADE: 25-AUG-09 GAHANNA OH 43230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SATURN ACTIVE LASER SYSTEM RESEARCH INSTRUMENTS LTD. 510(k) NO: K083208(ABBREVIATED)
ATTN: PHONE NO : BICKLAND INDUSTRIAL PARK SE DECISION MADE: 25-AUG-09 FALMOUTH, CORNWALL UK TR11 4TA510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A CONTEC MEDICAL SYSTEM CO., LTD. 510(k) NO: K090936(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 64264467 SUITE 8D , ZHONGXIN ZHONGSHAN MANSSE DECISION MADE: 25-AUG-09 ZHONG SHAN, SHANGHAI CH 20030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTURI NPWT V. II ADVANCED VACUUM SYSTEM TALLEY MEDICAL 510(k) NO: K090258(TRADITIONAL)
ATTN: JACK VAN DYKE PHONE NO : 888 259 9994 1070 E. WIELAND RD. SE DECISION MADE: 25-AUG-09 LANSING MI 48906 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEAD FIXATION ARC AND TABLE BASE SURGIVISION, INC. 510(k) NO: K091439(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 713 723 4080 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 25-AUG-09 HOUSTON TX 77071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD VACYTAUBER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 36877 BECTON DICKINSON AND COMPANY (BD) 510(k) NO: K091292(TRADITIONAL)
ATTN: MARY ANN ALSBERGE PHONE NO : 201 847 3103 1 BECTON DRIVE. MC300 SE DECISION MADE: 25-AUG-09 FRANKLIN LAKES NJ 07417 1885 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019 TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K091897(SPECIAL)
ATTN: ERICA LI PHONE NO : 886 2 66258188 6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 25-AUG-09 TAIPEI COUNTY TW 24888 510(k) STATEMENT DEVICE: PROFEMUR HIP SYSTEM MODULAR NECKS WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K091423(TRADITIONAL)
ATTN: RYAN ROSS PHONE NO : 901 867 4401 5677 AIRLINE RD. SE DECISION MADE: 25-AUG-09 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES SYNTHES (USA) 510(k) NO: K091144(TRADITIONAL)
ATTN: ANDREA TASKER PHONE NO : 610 719 6920 1301 GOSHEN PKWY. SE DECISION MADE: 25-AUG-09 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERNER FETALINK (VERSION 1.0) CERNER CORP. 510(k) NO: K091251(TRADITIONAL)
ATTN: SHELLEY S LOOBY PHONE NO : 816 201 1368 2800 ROCKCREEK PKWY. SE DECISION MADE: 25-AUG-09 KANSAS CITY MO 64117 510(k) STATEMENT DEVICE: IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR IMASIGHT INC 510(k) NO: K092307(TRADITIONAL)
ATTN: JEAN CASAULT PHONE NO : 819 777 7979 10-925 DE LA CARRIERE BLVD SE DECISION MADE: 25-AUG-09 GATINEAU, QUEBEC CA J8Y 6W5 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ GE HEALTHCARE 510(k) NO: K092004(TRADITIONAL)
ATTN: ALAN TOTAH PHONE NO : 262 544 3424 3000 N. GRANDVIEW BLVD. SE DECISION MADE: 25-AUG-09 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORDICBRAINEX SOFTWARE, VERSION 1.0 NORDICIMAGINGLAB AS 510(k) NO: K092102(TRADITIONAL)
ATTN: CHANDANA GURUNG BHANDARI PHONE NO : 47 55 707095 MOLLENDALSVEIEN 65C SE DECISION MADE: 25-AUG-09 BERGEN NO 5009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2 HEMCON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K092357(SPECIAL)
ATTN: KEVIN HAWKINS PHONE NO : 503 245 0459 10575 SW CASCADE AVENUE SUITE 130 SE DECISION MADE: 25-AUG-09 PORTLAND OR 97223 4363 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMMANDER 111, MODEL CD300-CD399 CARDIOCOM LLC 510(k) NO: K091821(SPECIAL)
ATTN: JULIE BULVER PHONE NO : 763 588 9839 4050 OLSEN MEMORIAL HIGHWAY SUITE SE DECISION MADE: 25-AUG-09 MINNEAPOLIS MN 55422 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERBE HYBRID KNIFE ERBE USA, INC. 510(k) NO: K083608(TRADITIONAL)
ATTN: JOHN TARTAL PHONE NO : 770 955 4400 2225 NORTHWEST PKWY. SE DECISION MADE: 26-AUG-09 MARIETTA GA 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EKG-PLUS II SOFTWARE BIONET CO., LTD. 510(k) NO: K090895(TRADITIONAL)
ATTN: HL JUNG PHONE NO : 262 649 001 ROOM 431, LIFEOFFICETEL 61-3, YOIDSE DECISION MADE: 26-AUG-09 -GU, SEOUL KS 150-731 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGN HIP CONSTRUCT (SHC), MODEL: 701 SURGICAL IMPLANT GENERATION NETWOR510(k) NO: K083582(TRADITIONAL)
ATTN: DOUGLAS J DONNELLY PHONE NO : 509 371 1107 451 HILLS ST., SUITE B SE DECISION MADE: 26-AUG-09 RICHLAND WA 99354 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSUFLOW LEXION MEDICAL, LLC. 510(k) NO: K090456(TRADITIONAL)
ATTN: BERNARD HORWATH PHONE NO : 651 361 8041 5000 TOWNSHIP PKWY SE DECISION MADE: 26-AUG-09 ST. PAUL MN 55110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROSCOPE ORTHOPEDIC SCIENCES, INC 510(k) NO: K091398(TRADITIONAL)
ATTN: JAMES K BRANNON PHONE NO : 562 799 5550 3020 OLD RANCH PARKWAY SUITE 325 SE DECISION MADE: 26-AUG-09 SEAL BEACH CA 90740 510(k) STATEMENT DEVICE: COLLASORB COLLAGEN WOUND DRESSING HARTMANN-CONCO INC. 510(k) NO: K091338(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 800 729 9674 1468 HARWELL AVE. SE DECISION MADE: 26-AUG-09 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPECT FLU A & B THERMO FISHER SCIENTIFIC 510(k) NO: K092423(SPECIAL)
ATTN: MARY A SILVIUS PHONE NO : 913 895 4054 12150 SANTA FE DRIVE SE DECISION MADE: 26-AUG-09 LENEXA KS 66215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORE*IT DUAL SPIDENT CO., LTD. 510(k) NO: K092572(TRADITIONAL)
ATTN: I.S. WHANG PHONE NO : 823 281 94570 312, 151B-6L NAMDONGGONGDAN SE DECISION MADE: 26-AUG-09 INCHEON KS 405-821 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM BAYER HEALTHCARE 510(k) NO: K091820(SPECIAL)
ATTN: MARC HENN PHONE NO : 574 256 7719 430 SOUTH BEIGER STREET SE DECISION MADE: 26-AUG-09 MISHAWAKA IN 46544 510(k) STATEMENT DEVICE: INSPIRA HD, MODEL: NL1000 NEUROLOGICA CORPORATION 510(k) NO: K090811(ABBREVIATED)
ATTN: DONALD D FICKETT PHONE NO : 978 564 8523 14 ELECTRONICS AVENUE SE DECISION MADE: 27-AUG-09 DANVERS MA 01923 1011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINISILK FT EL.EN. ELECTRONIC ENGINEERING SPA 510(k) NO: K082040(TRADITIONAL)
ATTN: ANDREA TOZZI PHONE NO : 39 055 8826807 17 VIA BALDANZESE SE DECISION MADE: 27-AUG-09 CALENZANO IT 50041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND BECKMAN COULTER, INC. 510(k) NO: K083867(TRADITIONAL)
ATTN: TYLER FOUTCH PHONE NO : 952 368 1653 1000 LAKE HAZELTINE DR. SE DECISION MADE: 27-AUG-09 CHASKA MN 55318 1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K090869(TRADITIONAL)
ATTN: JESSICA SIXBERRY PHONE NO : 763 514 9849 7611 NORTHLAND DR. SE DECISION MADE: 27-AUG-09 MINNEAPOLIS MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WMT COMPOSITE DBM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K083270(TRADITIONAL)
ATTN: RYAN M BELANEY PHONE NO : 901 867 4778 5677 AIRLINE RD. SE DECISION MADE: 27-AUG-09 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEGUIN ANNULOPLASTY RING ST. JUDE MEDICAL 510(k) NO: K092310(SPECIAL)
ATTN: THOMAS RADEMACHER PHONE NO : 651 756 6473 177 EAST COUNTY ROAD B SE DECISION MADE: 27-AUG-09 ST. PAUL MN 55117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E9540 TOSHIBA AMERICA ELECTRONIC COMPONE510(k) NO: K092537(TRADITIONAL)
ATTN: JOHN KURZYDLO PHONE NO : 847 484 7092 2150 EAST LAKE COOK RD., SUITE 310SE DECISION MADE: 27-AUG-09 BUFFALO GROVE IL 60089 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MAMMOSITE MULTI LUMEN HOLOGIC, INC. 510(k) NO: K092405(SPECIAL)
ATTN: JENNIFER SULLIVAN PHONE NO : 508 263 8912 250 CAMPUS DRIVE SE DECISION MADE: 27-AUG-09 MARLBOROUGH MA 01750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO.X SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K092519(TRADITIONAL)
ATTN: SVEN KNOKE PHONE NO : 499 131 844687 HENKESTRASSE 127 SE DECISION MADE: 27-AUG-09 ERLANGEN GM 91052 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FOX SV PTA CATHETER ABBOTT VASCULAR 510(k) NO: K092286(SPECIAL)
ATTN: NADINE SMITH PHONE NO : 951 914 3311 3200 LAKESIDE DRIVE SE DECISION MADE: 27-AUG-09 SANTA CLARA CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM CORVENTIS, INC. 510(k) NO: K091971(SPECIAL)
ATTN: MADHURI BHAT PHONE NO : 408 790 9306 2033 GATEWAY PLACE SUITE 100 SE DECISION MADE: 27-AUG-09 SAN JOSE CA 95110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAVEON WRX BONE FIXATION SYSTEM SONOMA ORTHOPEDIC PRODUCTS, INC. 510(k) NO: K090304(TRADITIONAL)
ATTN: CARLOS GONZALEZ PHONE NO : 707 526 1335 650 LARKFIELD CENTER SUITE C SE DECISION MADE: 28-AUG-09 SANTA ROSA CA 95403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAGIS ENDOSCOPIC INSTRUMENTS LAGIS ENTERPRISES CO, LTD. 510(k) NO: K090309(TRADITIONAL)
ATTN: JOSEPH J CHANG PHONE NO : 832 545 8399 7128 STAFFORDSHIRE ST. SE DECISION MADE: 28-AUG-09 HOUSTON TX 77030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINUS QUICK EB SYSTEM NEOBIOTECH CO., LTD. 510(k) NO: K090377(TRADITIONAL)
ATTN: JUNG B BANG PHONE NO : 562 404 8466 13340E FIRESTONE BLVD. STE. J SE DECISION MADE: 28-AUG-09 SANTE FE SPRINGS CA 90670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMER PLUS BISCO, INC. 510(k) NO: K091705(TRADITIONAL)
ATTN: MICHELLE SCHILTZ-TAING PHONE NO : 847 534 6000 1100 WEST IRVING PARK RD. SE DECISION MADE: 28-AUG-09 SCHAUMBURG IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VICKS POWERSHOT DRY THROAT & MOUTH RELIEF THE PROCTER & GAMBLE CO. 510(k) NO: K091419(TRADITIONAL)
ATTN: RICHARD J COOKE PHONE NO : 513 622 0208 8700 MASON-MONTGOMERY ROAD SE DECISION MADE: 28-AUG-09 MASON OH 45040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500 MAQUET CARDIOVASCULAR, LLC 510(k) NO: K091733(SPECIAL)
ATTN: ARTIE KAUSHIK PHONE NO : 408 635 3987 170 BAYTECH DRIVE SE DECISION MADE: 28-AUG-09 SAN JOSE CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEDA QUANTEL DERMA GMBH 510(k) NO: K090762(TRADITIONAL)
ATTN: DIETMAR FISCHER PHONE NO : 49 913 19408840 AM WOLFSMANTEL 46 SE DECISION MADE: 28-AUG-09 ERLANGEN GM D-91058 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: QUATTRO PORCELAIN SYSTEM DENTSPLY INTERNATIONAL, INC. 510(k) NO: K091706(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717 849 4229 221 WEST PHILADELPHIA ST. SUITE 60SE DECISION MADE: 28-AUG-09 YORK PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELVIS HSV ID AND D3 TYPING TEST SYSTEM DIAGNOSTIC HYBRIDS, INC. 510(k) NO: K091753(TRADITIONAL)
ATTN: RONALD H LOLLAR PHONE NO : 740 589 3300 1055 EAST STATE STREET SUITE 100 SE DECISION MADE: 28-AUG-09 ATHENS OH 45701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT DIAGNOSTIC HYBRIDS, INC. 510(k) NO: K092300(SPECIAL)
ATTN: RONALD H LOLLAR PHONE NO : 740 589 3300 1055 EAST STATE STREET SUITE 100 SE DECISION MADE: 28-AUG-09 ATHENS OH 45701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90 BEST MEDICAL CANADA LTD. 510(k) NO: K092285(SPECIAL)
ATTN: MARY HERBERT PHONE NO : 613 591 2100 413 MARCH ROAD SE DECISION MADE: 28-AUG-09 OTTAWA, ONTARIO CA K2K 034 510(k) STATEMENT DEVICE: PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2 ISORAY MEDICAL, INC. 510(k) NO: K092458(SPECIAL)
ATTN: FRED SWINDLER PHONE NO : 509 375 1202 350 HILLS ST., SUITE 106 SE DECISION MADE: 28-AUG-09 RICHLAND WA 99354 5411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT VORTEX MEDICAL INC 510(k) NO: K092486(TRADITIONAL)
ATTN: BRIAN KUNST PHONE NO : 518 796 6346 42 HORICON AVE. SE DECISION MADE: 28-AUG-09 GLENS FALLS NY 12801 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CARESCAPE MONITOR B850 GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K092027(TRADITIONAL)
ATTN: JOEL C KENT PHONE NO : 781 449 8685 86 PILGRIN RD. SE DECISION MADE: 28-AUG-09 NEEDHAM MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS ARTHREX, INC. 510(k) NO: K091844(SPECIAL)
ATTN: IVETTE GALMEZ PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 28-AUG-09 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS VASCUTEK LTD. 510(k) NO: K091778(TRADITIONAL)
ATTN: KAREN KELSO PHONE NO : 141 812 5555 NEWMAINS AVE. INCHINNAN INDUSTRIALSE DECISION MADE: 31-AUG-09 RENFREWSHIRE,GLASGOW,SCOTLAND U510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRINDGUARD GRIND GUARD TECHNOLOGIES, LLC 510(k) NO: K082723(TRADITIONAL)
ATTN: BILL MCLAIN PHONE NO : 717 656 9656 342 E. MAIN STREET SUITE 207 SE DECISION MADE: 31-AUG-09 LEOLA PA 17540 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VS-SENSE TEST COMMON SENSE, LTD. 510(k) NO: K091287(TRADITIONAL)
ATTN: NATASHA LESKOVSEK PHONE NO : 202 728 7131 777 6TH STREET NW SUITE 1100 SE DECISION MADE: 31-AUG-09 WASHINGTON DC 20001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358 RTI BIOLOGICS, INC. 510(k) NO: K091142(SPECIAL)
ATTN: TRAVIS AROLA PHONE NO : 386 418 8888 11621 RESEARCH CIRCLE P.O. BOX 265SE DECISION MADE: 31-AUG-09 ALACHUA FL 32616 1627 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 211 TOTAL WITH SUMMARIES 191 TOTAL WITH STATEMENTS 20
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