Medical Devices
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September 2011 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD September 2011 DEVICE: MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG MEDIPURPOSE PTE. LTD. 510(k) NO: K110062(TRADITIONAL) ATTN: JULIE STEPHENS PHONE NO : 678 513 0693 111 LAUREL RIDGE DRIVE SE DECISION MADE: 01-SEP-11 ALPHARETTA GA 30004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE BIOMET 3I, INC. 510(k) NO: K110565(TRADITIONAL) ATTN: JOSE E CABRERA PHONE NO : 561 776 6840 4555 RIVERSIDE DR. SE DECISION MADE: 01-SEP-11 PALM BEACH GARDENS FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLY-CHEM 90 TOTAL BILIRUBIN POLYMEDCO, INC. 510(k) NO: K111143(TRADITIONAL) ATTN: HELEN LANDICHO PHONE NO : 206 402 6146 510 FURNACE DOCK RD. SE DECISION MADE: 01-SEP-11 CORTLANDT MANOR NY 10567 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM FUJIFILM MEDICAL SYSTEMS, USA INC.510(k) NO: K110729(TRADITIONAL) ATTN: PETER ALTMAN PHONE NO : 203 602 3576 419 WEST AVENUE SE DECISION MADE: 01-SEP-11 STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES WANGDA PLASTIC CO., LTD 510(k) NO: K110944(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 RM 1606 BLDG 1, JIANXIANG YUAN NO SE DECISION MADE: 01-SEP-11 HAIDIAN DISTRICT, BEIJING CH 10510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES STERIS CORPORATION 510(k) NO: K103331(TRADITIONAL) ATTN: ROBERT F SULLIVAN PHONE NO : 440 392 7695 5960 HEISLEY ROAD SE DECISION MADE: 01-SEP-11 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROMA (HE4 EIA + ARCHITECT CA 125 II) FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K103358(TRADITIONAL) ATTN: DIANA L DICKSON PHONE NO : 610 240 3917 201 GREAT VALLEY PKWY. SE DECISION MADE: 01-SEP-11 MALVERN PA 19355 1307 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) GYRUS ACMI, INC. 510(k) NO: K111059(TRADITIONAL) ATTN: LORRAINE CALZETTA PHONE NO : 508 804 2752 136 TURNPIKE RD. SE DECISION MADE: 01-SEP-11 SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAPPHIRE NC ORBUSNEICH MEDICAL, INC. 510(k) NO: K103808(TRADITIONAL) ATTN: JOHN PAZIENZA PHONE NO : 954 730 0711 5363 N.W. 35TH AVE. SE DECISION MADE: 01-SEP-11 FT. LAUDERDALE FL 33309 6315 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K112349(SPECIAL) ATTN: ANGELA V ARSDALE PHONE NO : 203 492 5496 60 Middletown Ave SE DECISION MADE: 01-SEP-11 North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMG SUCTION UNIT EMG TECHNOLOGY CO., LTD. 510(k) NO: K112421(TRADITIONAL) ATTN: PAUL CHO PHONE NO : 886 423 596033 NO.58, 35 RD, TAICHUNG INDUSTRIAL SE DECISION MADE: 01-SEP-11 TAICHUNG TW 40768 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ALP 501 RB PUMP SYSTEM CURRIE MEDICAL SPECIALTIES, INC. 510(k) NO: K112311(SPECIAL) ATTN: BERNICE NAVARRO PHONE NO : 626 303 3521 730 EAST LOS ANGELES AVE. SE DECISION MADE: 01-SEP-11 MONROVIA CA 91016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1) LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K112199(SPECIAL) ATTN: LUBNA SYED PHONE NO : 416 593 4323 439 UNIVERSITY AVE. SUITE 900 SE DECISION MADE: 01-SEP-11 TORONTO, ONTARIO CA M5G 1Y8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM GE HEALTHCARE 510(k) NO: K112213(TRADITIONAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 W. INNOVATION DRIVE SE DECISION MADE: 01-SEP-11 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORA G20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K101631(TRADITIONAL) ATTN: TELING HSU PHONE NO : 866 266 258188 3F, 5F, NO 127 WUGONG 2ND RD WUGU SE DECISION MADE: 02-SEP-11 TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEM-TONE BODY TRAINING SYSTEM GEMORE TECHNOLOGY CO., LTD. 510(k) NO: K102933(TRADITIONAL) ATTN: BODEN S LAI PHONE NO : 886 288 091799 11 FL, NO. 29-5, SEC. 2 CHUNG CHENSE DECISION MADE: 02-SEP-11 TAN SHUI, TAIPEI HSIEN TW 251 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION ZIMMER, INC. 510(k) NO: K110791(TRADITIONAL) ATTN: ANTHONY FRANCALANCIA PHONE NO : 574 372 4570 P.O. BOX 708 SE DECISION MADE: 02-SEP-11 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMP A-I-R OMRON HEALTHCARE, INC. 510(k) NO: K110860(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 02-SEP-11 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROSIM 4, PROSIM 6, PROSIM 8 FLUKE BIOMEDICAL 510(k) NO: K110429(TRADITIONAL) ATTN: JOHN NELSON PHONE NO : 440 498 2579 6045 COCHRAN RD. SE DECISION MADE: 02-SEP-11 SOLON OH 44139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U ANSELL HEALTHCARE PRODUCTS, INC. 510(k) NO: K111139(TRADITIONAL) ATTN: NEIL BURRIS PHONE NO : 303 223 4336 555 ZANG STREET SUITE 100 SE DECISION MADE: 02-SEP-11 LAKEWOOD CO 80228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IP TEMP CEMENT SHOFU DENTAL CORPORATION 510(k) NO: K111685(TRADITIONAL) ATTN: DAVID P MORAIS PHONE NO : 760 736 3277 1225 STONE DRIVE SE DECISION MADE: 02-SEP-11 SAN MARCOS CA 92078 510(k) STATEMENT DEVICE: AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS STERIS CORPORATION 510(k) NO: K111810(SPECIAL) ATTN: ROBERT SULLIVAN PHONE NO : 440 354 2600 5960 HEISLEY ROAD SE DECISION MADE: 02-SEP-11 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSUTURE ANCHORS ARTHREX, INC. 510(k) NO: K112237(SPECIAL) ATTN: COURTNEY SMITH PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 02-SEP-11 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL RADIOGRAPHY CANON, INC.-MEDICAL EQUIPMENT GROU510(k) NO: K111682(SPECIAL) ATTN: KOJI KUBO PHONE NO : 81 425 481253 C/O COSMOS CORPORATION 3F 2-17-6 ASE DECISION MADE: 02-SEP-11 TACHIKAWA-SHI, TOKYO JA 190-001510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL RADIOGRAPHY CANON, INC.-MEDICAL EQUIPMENT GROU510(k) NO: K112309(SPECIAL) ATTN: KOJI KUBO PHONE NO : 814 254 81253 3F 2-17-6 AKEBONO-CHO SE DECISION MADE: 02-SEP-11 TACHIKAWA-SHI, TOKYO JA 190-001510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NM-7000 NUGA MEDICAL CO., LTD 510(k) NO: K111329(TRADITIONAL) ATTN: CHARLIE MACK PHONE NO : 541 376 5063 77325 JOYCE WAY SE DECISION MADE: 06-SEP-11 ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FULL CORE BIOPSY SYSTEM PROMEX TECHNOLOGIES, LLC 510(k) NO: K111765(TRADITIONAL) ATTN: ALLISON SCOTT PHONE NO : 317 569 9500 9001 WESLEYAN ROAD SE DECISION MADE: 06-SEP-11 INDIANAPOLIS IN 46268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XTRA SORIN GROUP ITALIA S.R.L 510(k) NO: K112245(SPECIAL) ATTN: BARRY SALL PHONE NO : 781 434 4742 PAREXEL CONSULTING 195 WEST STREETSE DECISION MADE: 06-SEP-11 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERALAS 980NM DIODE LASER FAMILY BIOLITEC MEDICAL DEVICES, INC 510(k) NO: K112324(TRADITIONAL) ATTN: HARRY HAYES PHONE NO : 413 250 0779 1349 MAIN ROAD SE DECISION MADE: 06-SEP-11 GRANDVILLE MA 01034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... IMMUNODIAGNOSTIC SYSTEMS LTD. 510(k) NO: K111650(ABBREVIATED) ATTN: MICK FENTON PHONE NO : 440 191 5190660 10 DIDCOT WAY, BOLDEN BUSINESS PARSE DECISION MADE: 06-SEP-11 BOLDON, TYNE & WEAR UK NE35 9PD510(k) STATEMENT DEVICE: HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON TGM MEDICAL 510(k) NO: K111472(TRADITIONAL) ATTN: DENNIS H CRANE PHONE NO : 952 374 6012 5145 GOLDEN FOOTHILL PARKWAY SUITESE DECISION MADE: 06-SEP-11 EL DORADO CA 95762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYSAFETY SYRINGE MEDICALCHAIN INTL. CORP. 510(k) NO: K111734(SPECIAL) ATTN: ROBIN HWANG PHONE NO : 805 376 0372 1808 SEABREEZE COUNT, SE DECISION MADE: 06-SEP-11 THOUSAND OAKS CA 91320 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM CILAG GMBH INTERNATIONAL 510(k) NO: K110637(TRADITIONAL) ATTN: FIONA LEEPER PHONE NO : 440 146 3721596 LANDIS AND GYR STRASSE 1 SE DECISION MADE: 07-SEP-11 ZUG SZ 6300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORELEADER HEMO-PAD MODEL CPII 02030 CORELEADER BIOTECH CO., LTD. 510(k) NO: K102944(TRADITIONAL) ATTN: IAN LI PHONE NO : 886 226 968880 19F NO. 100, SEC 1 SINTAI 5TH RD, SE DECISION MADE: 07-SEP-11 TAIPEI, TAIWAN TW 22102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVADYNE TEMPORARY CROWN AND BRIDGE RESIN NEO DENTAL CHEMICAL PRODUCTS CO., 510(k) NO: K111666(TRADITIONAL) ATTN: ROBERT SEIPLE PHONE NO : 512 327 9997 611 WEST 5TH STREET SE DECISION MADE: 07-SEP-11 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PILOT SPINAL SYSTEM LIFE SPINE, INC 510(k) NO: K111729(SPECIAL) ATTN: RANDY LEWIS PHONE NO : 847 884 6117 2401 W. HASSELL RD SUITE 1535 SE DECISION MADE: 07-SEP-11 HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPAL BAND CEMENT ULTRADENT PRODUCTS, INC. 510(k) NO: K111696(TRADITIONAL) ATTN: DIANE ROGERS PHONE NO : 801 553 4491 505 WEST 10200 SOUTH SE DECISION MADE: 07-SEP-11 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNITE BIOMATRIX SYNOVIS ORTHOPEDIC & WOUNDCARE 510(k) NO: K112399(SPECIAL) ATTN: AMY BOUCLY PHONE NO : 949 502 3240 6 Jenner, Suite 150 SE DECISION MADE: 07-SEP-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. 510(k) NO: K112272(SPECIAL) ATTN: YC LEI PHONE NO : 886 366 86868 NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 07-SEP-11 HSINCHU CITY, HSINCHU TW 30077 510(k) STATEMENT DEVICE: A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.) SPINEWORKS, LLC 510(k) NO: K111166(TRADITIONAL) ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD. SE DECISION MADE: 08-SEP-11 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROLINK ADHESIVES (PROLINK, PROLINK SE) SILMET LTD. 510(k) NO: K110403(TRADITIONAL) ATTN: MOSHE ZALSMAN PHONE NO : 972 373 53000 12 HASSADNA ST. SE DECISION MADE: 08-SEP-11 OR YEHUDA IS 60200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K103615(TRADITIONAL) ATTN: HYMAN KATZ PHONE NO : 973 852 0158 4 HENDERSON DRIVE SE DECISION MADE: 08-SEP-11 WEST CALDWELL NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS POLYMEDCO, INC. 510(k) NO: K110818(TRADITIONAL) ATTN: HELEN LANDICHO PHONE NO : 206 402 6146 510 FURNACE DOCK RD. SE DECISION MADE: 08-SEP-11 CORTLANDT MANOR NY 10567 510(k) STATEMENT DEVICE: FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI OCULUS PRIVATE LIMITED 510(k) NO: K103132(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720 962 5412 5401 S COTTONWOOD CT. SE DECISION MADE: 08-SEP-11 GREENWOOD VILLAGE CO 80121 510(k) STATEMENT DEVICE: SV BRAIN ARRAY, SIEMENS 3T MRI INTERVENTIONS, INC. 510(k) NO: K111802(TRADITIONAL) ATTN: E.F. WADDELL PHONE NO : 949 900 6833 5 Musick SE DECISION MADE: 08-SEP-11 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RTVUE CAM WITH CORNEAL POWER UPGRADE OPTOVUE, INC. 510(k) NO: K111505(TRADITIONAL) ATTN: JOHN TALARICO PHONE NO : 510 623 8868 45531 NORTHPORT LOOP W. SE DECISION MADE: 08-SEP-11 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLINE VIAL DECANTER MEDLINE INDUSTRIES, INC. 510(k) NO: K111577(TRADITIONAL) ATTN: MATT CLAUSEN PHONE NO : 847 643 4785 ONE MEDLINE PLACE SE DECISION MADE: 08-SEP-11 MUNDELEIN IL 60060 510(k) STATEMENT DEVICE: XELIS FUSION INFINITT CO., LTD. 510(k) NO: K111613(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 469 684 1980 1600 MANCHESTER WAY SE DECISION MADE: 08-SEP-11 CORINTH TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WONDFO METHADONE URINE TEST,OPIATE TEST GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K112310(TRADITIONAL) ATTN: JOE SHIA PHONE NO : 240 505 7880 504 EAST DIAMOND AVE. SUITE F SE DECISION MADE: 08-SEP-11 GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNI PATIENT MONITOR INFINIUM MEDICAL 510(k) NO: K112329(SPECIAL) ATTN: JOHN O'BRIEN PHONE NO : 813 645 2855 962 ALLEGRO LN. SE DECISION MADE: 08-SEP-11 APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREFILLED CATHETER INFLATION SYRINGE AVAIL MEDICAL PRODUCTS, INC. 510(k) NO: K112209(SPECIAL) ATTN: STEVEN A HOWELL PHONE NO : 858 457 1988 5950 NANCY RIDGE ROAD SUITE 500 SE DECISION MADE: 08-SEP-11 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIXATE TISSUE BAND ANULEX TECHNOLOGIES, INC 510(k) NO: K111462(TRADITIONAL) ATTN: RACHEL KENNEDY PHONE NO : 952 224 4000 5600 ROWLAND ROAD, STE 280 SE DECISION MADE: 08-SEP-11 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM COLOPLAST CORP. 510(k) NO: K112386(SPECIAL) ATTN: TIM CRABTREE PHONE NO : 612 302 4922 1601 WEST RIVER N SE DECISION MADE: 08-SEP-11 MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE VEO RECONSTRUCTION OPTION GENERAL ELECTRIC CO. 510(k) NO: K103489(TRADITIONAL) ATTN: ANDREW J MENDEN PHONE NO : 262 312 7068 3000 N. GRANDVIEW BLVD. W1140 SE DECISION MADE: 09-SEP-11 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYOPEN CRYOSURGICAL SYSTEM, K102214 CRYOPEN, INC. 510(k) NO: K110754(TRADITIONAL) ATTN: MIKE HAAS, M.D. PHONE NO : 877 246 3955 577 COMMERCE ST SUITE B SE DECISION MADE: 09-SEP-11 SOUTHLAKE TX 76092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IFS PROFILE PLATES, SCREWS, AND WASHERS INTERNAL FIXATION SYSTEMS, INC. 510(k) NO: K110086(TRADITIONAL) ATTN: CHRIS ENDARA PHONE NO : 305 884 5993 10100 N.W. 116TH WAY, STE. 18 SE DECISION MADE: 09-SEP-11 MIAMI FL 33178 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MRGFUS PELVIC PA COIL MODEL 1.0 INSIGHTECH, LTD 510(k) NO: K111060(SPECIAL) ATTN: ORI LUBIN PHONE NO : 972 544 881399 5 NAHUM HETH ST. SE DECISION MADE: 09-SEP-11 TIRAT CARMEL IS 39120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 DATEX-OHMEDA 510(k) NO: K111116(TRADITIONAL) ATTN: MONICA MORRISON PHONE NO : 608 221 1551 PO BOX 7550 3030 OHMEDA DR SE DECISION MADE: 09-SEP-11 MADISON WI 53707 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING SALIENT SURGICAL TECHNOLOGIES, INC510(k) NO: K111285(TRADITIONAL) ATTN: RITA M CALNAN PHONE NO : 603 842 6313 180 INTERNATIONAL DRIVE SE DECISION MADE: 09-SEP-11 Portsmouth NH 03801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOTEQ ANGIOGRAPHIC CATHETER BIOTEQUE CORP. 510(k) NO: K102633(TRADITIONAL) ATTN: JENNIFER REICH PHONE NO : 928 863 8140 2904 N BOLDT DRIVE SE DECISION MADE: 09-SEP-11 FLAGSTAFF AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE ASAHI INTECC CO., LTD. 510(k) NO: K101986(SPECIAL) ATTN: YOSHI TERAI PHONE NO : 949 756 8252 2500 RED HILL SUITE 210 SE DECISION MADE: 09-SEP-11 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX AVINGER, INC. 510(k) NO: K111704(TRADITIONAL) ATTN: SEVRINA CIUCCI, RAC PHONE NO : 408 316 4837 400 CHESAPEAKE DRIVE SE DECISION MADE: 09-SEP-11 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIMAX ANTI-FOG SOLUTION UNIMAX MEDICAL SYSTEMS, INC. 510(k) NO: K111622(TRADITIONAL) ATTN: MICHAEL LEE PHONE NO : 886 228 096995 NO. 45, MINSHEN RD. DANSHUI TOWN SE DECISION MADE: 09-SEP-11 TAIPEI COUNTY TW 251 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSKELETON(R) TAS TITAN SPINE, LLC 510(k) NO: K111626(TRADITIONAL) ATTN: RICH JANSEN PHONE NO : 612 281 5505 13540 GUILD AVE SE DECISION MADE: 09-SEP-11 APPLE VALLEY MN 55124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW RJ CONSTRAINED LINERS SMITH & NEPHEW, INC. 510(k) NO: K111635(TRADITIONAL) ATTN: MEGAN BEVILL PHONE NO : 901 399 5340 1450 BROOKS RD. SE DECISION MADE: 09-SEP-11 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOSHIBA 3T EXTRA LARGE KNEE COIL QUALITY ELECTRODYNAMICS 510(k) NO: K112313(SPECIAL) ATTN: CHRISTIE ZYDYK PHONE NO : 440 484 2228 700 BETA DR. SUITE 100 SE DECISION MADE: 09-SEP-11 MAYFIELD VILLAGE OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLOSUREFAST RADIOFREQUENCY CATHETER COVIDIEN 510(k) NO: K111887(SPECIAL) ATTN: DANIEL CAMPION PHONE NO : 508 452 4135 15 HAMPSHIRE STREET SE DECISION MADE: 09-SEP-11 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES CARDIAC ASSIST, MAQUET CARDIOVASCU510(k) NO: K112327(SPECIAL) ATTN: HELDER A SOUSA PHONE NO : 201 995 8710 1300 Macarthur Blvd SE DECISION MADE: 09-SEP-11 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K112395(TRADITIONAL) ATTN: JOE SHIA PHONE NO : 240 505 7880 504 EAST DIAMOND AVE SUITE F SE DECISION MADE: 09-SEP-11 GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESOLUTIONMD MOBILE MODEL RMB-MOB-2X CALGARY SCIENTIFIC, INC. 510(k) NO: K111346(TRADITIONAL) ATTN: KYLE PETERSON PHONE NO : 403 76 77945 SUITE 208, 1210 20TH AVENUE SE SE DECISION MADE: 09-SEP-11 CALGARY, ALBERTA CA T2G 1M8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: .DECIMAL ELECTRON APERTURE .DECIMAL, INC. 510(k) NO: K111759(TRADITIONAL) ATTN: DANIEL L BENNETT PHONE NO : 407 330 3300 121 CENTRAL PARK PLACE SE DECISION MADE: 09-SEP-11 SANFORD FL 32771 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATERPAP VALVE AIRWAYS DEVELOPMENT, LLC 510(k) NO: K110713(TRADITIONAL) ATTN: RICHARD J LARKIN PHONE NO : 973 889 3611 P.O. BOX 558 SE DECISION MADE: 12-SEP-11 CEDAR KNOLLS NJ 07927 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JUELL HARD CURE JUELL DENTAL 510(k) NO: K111177(TRADITIONAL) ATTN: ANGELA BLACKWELL PHONE NO : 704 450 9934 2401 N COMMERCE SE DECISION MADE: 12-SEP-11 ARDMORE OK 73401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JUELL SOFT CURE JUELL DENTAL 510(k) NO: K111178(TRADITIONAL) ATTN: ANGELA BLACKWELL PHONE NO : 704 450 9934 2401 N COMMERCE SE DECISION MADE: 12-SEP-11 ARDMORE OK 73401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRAUMANN TIBRUSH STRAUMANN USA 510(k) NO: K111724(TRADITIONAL) ATTN: ELAINE ALAN PHONE NO : 978 747 2513 60 MINUTEMAN ROAD SE DECISION MADE: 12-SEP-11 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISCOVERY INTUITIVE SPINE, LLC 510(k) NO: K111484(TRADITIONAL) ATTN: JENNIFER PALINCHIK PHONE NO : 440 933 8850 33490 PIN OAK PARKWAY SE DECISION MADE: 12-SEP-11 AVON LAKE OH 44012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REKA E100 REKA PTE LTD 510(k) NO: K111438(ABBREVIATED) ATTN: LARRY PETERSEN PHONE NO : 303 489 2500 1001 BEAR ISLAND ROAD SUITE 136 SE DECISION MADE: 12-SEP-11 SUMMERVILLE SC 29483 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTSHEARS NUSCIENCE CONSULTING AND MANAGEMEN510(k) NO: K112400(TRADITIONAL) ATTN: NIKOLE GOLDSMITH PHONE NO : 904 537 9595 P.O. BOX 8507 SE DECISION MADE: 12-SEP-11 FLEMING ISLAND FL 32006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA.. CENDRES & METAUX SA 510(k) NO: K111390(SPECIAL) ATTN: TANJA BONGNI PHONE NO : 41 58 3602302 RUE DE BOUJEAN 122 SE DECISION MADE: 12-SEP-11 BIEL/BIENNE SZ 2501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 SUNSET HEALTHCARE SOLUTIONS, LLC 510(k) NO: K102483(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720 952 5412 5401 S. COTTONWOOD CT. SE DECISION MADE: 13-SEP-11 GREENWOOD VILLAGE CO 80121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLGATE DESENSITIZING DENTAL CREAM COLGATE-PALMOLIVE CO. 510(k) NO: K103461(TRADITIONAL) ATTN: CHARLES P IRELAND PHONE NO : 732 878 7500 909 RIVER RD. SE DECISION MADE: 13-SEP-11 PISCATAWAY NJ 08855 1343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER LEMAITRE VASCULAR INC. 510(k) NO: K110891(TRADITIONAL) ATTN: ANDREW HODGKINSON PHONE NO : 781 221 2266 63 SECOND AVENUE SE DECISION MADE: 13-SEP-11 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES ZHAOYANG PLASTIC CO., LTD 510(k) NO: K110945(TRADITIONAL) ATTN: CHU ZIAOAN PHONE NO : 861 082 387441 RM 1606 BLDG 1, JIANXIANG YUAN NO SE DECISION MADE: 13-SEP-11 HAIDIAN DISTRICT, BEIJING CH 10510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REUSABLE STIMULATING ELECTRODES ADVENA LTD 510(k) NO: K111270(TRADITIONAL) ATTN: JUDY BURTON PHONE NO : 972 243 5105 3010 LBJ FRWY 12TH FLOOR SE DECISION MADE: 13-SEP-11 DALLAS TX 75234 510(k) STATEMENT DEVICE: EPISIL CAMURUS AB 510(k) NO: K101769(TRADITIONAL) ATTN: MAUREEN O'CONNELL PHONE NO : 978 207 1245 5 TIMBER LANE SE DECISION MADE: 13-SEP-11 NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION ALMA LASERS, INC. 510(k) NO: K112031(SPECIAL) ATTN: ANNE WORDEN PHONE NO : 925 895 1200 485 HALF DAY RD. SUITE NO. 100 SE DECISION MADE: 13-SEP-11 BUFFALO GROVE IL 60089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XELIS CARDIAC INFINITT CO., LTD. 510(k) NO: K111660(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 469 684 1980 1600 MANCHESTER WAY SE DECISION MADE: 13-SEP-11 CORINTH TX 76521 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHEAUMANN PL-1064 SHEAUMANN LASERS 510(k) NO: K111359(TRADITIONAL) ATTN: TIMOTHY J SHEA PHONE NO : 407 590 2050 189 WINDING OAKS LANE SE DECISION MADE: 13-SEP-11 OVIEDO FL 32765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMCOM COMMTECH MESSENGER AMCOM SOFTWARE,INC. 510(k) NO: K112047(TRADITIONAL) ATTN: THOMAS KROENKE PHONE NO : 303 956 4232 PO BOX 3018 SE DECISION MADE: 13-SEP-11 NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICAL CONCEPTS INTERBODY FUSION SYSTEM MEDICAL CONCEPTS, INC. 510(k) NO: K110659(TRADITIONAL) ATTN: CHRISTOPHER CANIS PHONE NO : 512 626 9599 11467 HUEBNER RD SUITE #350 SE DECISION MADE: 13-SEP-11 SAN ANTONIO TX 78230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM QUALIREG RESOURCES LLC 510(k) NO: K111115(SPECIAL) ATTN: JOHN SANDERS PHONE NO : 954 993 5581 2361 NW 105TH LANE SE DECISION MADE: 13-SEP-11 SUNRISE FL 33322 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JBAIDS INFLUENZA A SUBTYPING KIT U.S. ARMY MEDICAL MATERIEL DEVELOP510(k) NO: K111778(TRADITIONAL) ATTN: PATRICIA M BEVERLY PHONE NO : 301 619 2980 1430 VETERANS DRIVE SE DECISION MADE: 13-SEP-11 FORT DETRICK MD 21702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JBAIDS INFLUENZA A&B DETECTION KIT U.S. ARMY MEDICAL MATERIAL DEVELOP510(k) NO: K111775(TRADITIONAL) ATTN: PATRICIA BEVERLY PHONE NO : 301 619 2980 1430 VETERANS DRIVE SE DECISION MADE: 13-SEP-11 FORT DETRICK MD 21702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LITE PELVIC FLOOR REPAIR KITS BOSTON SCIENTIFIC CORP. 510(k) NO: K103426(ABBREVIATED) ATTN: MICHELLE BERRY PHONE NO : 508 683 4941 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 14-SEP-11 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLLAGEN POWDER INNOCOLL PHARMACEUTICALS LTD 510(k) NO: K103648(TRADITIONAL) ATTN: AARON WYSE PHONE NO : 353 090 6666091 MIDLANDS RESEARCH AND INNOVATION CSE DECISION MADE: 14-SEP-11 ATHLONE, CO. WESTMEATH EI EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KJ SUBMERGED SYSTEM KJ MEDITECH CO., LTD 510(k) NO: K103810(TRADITIONAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080 951 STARBUCK ST. UNIT J SE DECISION MADE: 14-SEP-11 FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOB ONE STEP RAPID TEST ORIENT GENE BIOTECH 510(k) NO: K110309(TRADITIONAL) ATTN: GARY LEHNUS PHONE NO : 570 620 0198 150 CHERRY LANE RD SE DECISION MADE: 14-SEP-11 EAST STROUDSBURG PA 18301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD CHEMTRON BIOTECH, INC. 510(k) NO: K111322(TRADITIONAL) ATTN: JANE ZHANG PHONE NO : 858 530 2868 8370 JUNIPER CREEK LANE SUITE 1-2 SE DECISION MADE: 14-SEP-11 SAN DIEGO CA 92126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITAL SIGNS MONITOR ADVANCED INSTRUMENTS, INC. 510(k) NO: K112465(TRADITIONAL) ATTN: JORGE MILLAN PHONE NO : 305 925 1260 601 WEST 20 ST SE DECISION MADE: 14-SEP-11 HIALEAH FL 33010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS MYOGLOBIN CALCHECK 5 ROCHE DIAGNOSTICS 510(k) NO: K112113(TRADITIONAL) ATTN: KELLY COLLEEN O'MAINE ADAMSPHONE NO : 317 521 3577 9115 HAGUE ROAD SE DECISION MADE: 14-SEP-11 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PADLOCK RELIANCE ORTHODONTIC PRODUCTS, INC510(k) NO: K111814(SPECIAL) ATTN: PAULA WENDLAND PHONE NO : 630 773 4009 1540 WEST THORNDALE AVE. SE DECISION MADE: 14-SEP-11 ITASCA IL 60143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE BOSTON SCIENTIFIC CORPORATION 510(k) NO: K112198(SPECIAL) ATTN: ASHLEY PYLE PHONE NO : 508 683 4359 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 14-SEP-11 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL RETINAL CAMERA CANON, INC. 510(k) NO: K111612(SPECIAL) ATTN: KOJI KUBO PHONE NO : 814 254 81253 TOKYO OFFICE 6-5-3 BEAUNE HONKOMAGSE DECISION MADE: 14-SEP-11 HONKOMAGOME, BUNKYO-KU TOKYO JA510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCTOTMPORT DALIM SURGNET CORPORATION 510(k) NO: K112196(SPECIAL) ATTN: APRIL LEE PHONE NO : 714 525 0114 325 N PUENTE ST. UNIT B SE DECISION MADE: 14-SEP-11 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHEAUMANN PL-980 SHEAUMANN LASERS 510(k) NO: K111360(TRADITIONAL) ATTN: TIMOTHY J SHEA PHONE NO : 407 590 2050 189 WINDING OAKS LANE SE DECISION MADE: 14-SEP-11 OVIEDO FL 32765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE INSYNC CERAMIC SYSTEM JENSEN INDUSTRIES, INC. 510(k) NO: K111743(ABBREVIATED) ATTN: GARY PHELPS PHONE NO : 203 239 2090 50 STILLMAN RD. SE DECISION MADE: 14-SEP-11 NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 ELITECHGROUP 510(k) NO: K111996(ABBREVIATED) ATTN: DEBRA K HUTSON PHONE NO : 425 482 5174 21720 23RD DR SE SUITE 150 SE DECISION MADE: 14-SEP-11 BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL BIODENTA SWISS AG 510(k) NO: K111003(TRADITIONAL) ATTN: DAVID EILER PHONE NO : 417 174 71111 TRAMSTRASSE 16 SE DECISION MADE: 15-SEP-11 BERNECK, ST. GALLEN SZ 9442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC VORTRAN MEDICAL TECHNOLOGY 1, INC.510(k) NO: K103639(TRADITIONAL) ATTN: JAMES LEE PHONE NO : 916 648 8460 21 GOLDEN LAND COURT SE DECISION MADE: 15-SEP-11 SACRAMENTO CA 95834 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Q-CLEAR LIGHT AGE, INC. 510(k) NO: K110370(TRADITIONAL) ATTN: ELIZABETH REDDINGTON PHONE NO : 732 563 0600 500 APGAR DRIVE SE DECISION MADE: 15-SEP-11 SOMERSET NJ 08873 1150 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KOLPLUX SYSTEM KOLPLAST CI LTDA 510(k) NO: K110766(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410 451 0639 1468 HARWELL AVENUE SE DECISION MADE: 15-SEP-11 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FEEL-DRCS IMFOU CO., LTD 510(k) NO: K110033(TRADITIONAL) ATTN: HO DONG YANG PHONE NO : 082 256 63360 #821 SAMIL PLAZA, 837-26 YEUKSAM-DSE DECISION MADE: 15-SEP-11 GANGNAM-GU, SEOUL KS 135-768 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EQUAL DOSE NUCLETRON CORPORATION 510(k) NO: K103515(TRADITIONAL) ATTN: MANAL YOUSOF PHONE NO : 443 545 2196 7021 COLUMBIA GATEWAY DR. SUITE 20SE DECISION MADE: 15-SEP-11 COLUMBIA MD 21046 2133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS MIS - IMPLANT TECHNOLOGIES LTD. 510(k) NO: K103089(TRADITIONAL) ATTN: IMAN KHORSHID PHONE NO : 972 4 9016800 BAR LEV INDUSTRIAL PARK P.O. BOX 7SE DECISION MADE: 15-SEP-11 BAR LEV INDUSTRIAL PARK IS 2015510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K111510(TRADITIONAL) ATTN: KEVIN FORD PHONE NO : 901 396 3133 1800 PYRAMID PL. SE DECISION MADE: 15-SEP-11 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASTRA CANDELIS, INC. 510(k) NO: K111694(TRADITIONAL) ATTN: VINCENT CIPOLLA PHONE NO : 949 798 8122 18821 BARDEEN AVE. SE DECISION MADE: 15-SEP-11 IRVINE CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4CH FLEX SPEEDER TOSHIBA MEDICAL SYSTEMS COPORATION510(k) NO: K112366(SPECIAL) ATTN: PAUL BIGGINS PHONE NO : 714 669 7808 2441 MICHELLE DR SE DECISION MADE: 15-SEP-11 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP CARDIAC ASSIST, MAQUET CARDIOVASCU510(k) NO: K112372(SPECIAL) ATTN: HELDER A SOUSA PHONE NO : 201 995 8710 1300 MACARTHUR BLVD. SE DECISION MADE: 15-SEP-11 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC COOPERVISION, INC. 510(k) NO: K111966(SPECIAL) ATTN: LISA HAHN PHONE NO : 585 385 6810 6150 STONERIDGE MALL ROAD SUITE 37SE DECISION MADE: 15-SEP-11 PLEASANTON CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT NESS-NEUROMUSCULAR ELECTRICAL STIM510(k) NO: K111767(TRADITIONAL) ATTN: MONICA STACHURA,JD PHONE NO : 661 362 4844 19 HA'HAROSHET ST. SE DECISION MADE: 15-SEP-11 RA'ANANA IS 43654 510(k) STATEMENT DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K111457(TRADITIONAL) ATTN: LEE GRANT PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 15-SEP-11 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM SPINAL USA 510(k) NO: K112025(TRADITIONAL) ATTN: FRANKIE CUMMINS PHONE NO : 601 420 4244 2050 EXECUTIVE DR. SE DECISION MADE: 15-SEP-11 PEARL MS 39208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOLECULAR BREAST IMAGING SOFTWARE GAMMA MEDICA-IDEAS INCORPORATED 510(k) NO: K111731(TRADITIONAL) ATTN: ALBERT BONISKE PHONE NO : 408 400 0856 755 N. MATHILDA AVENUE SUITE 100 SE DECISION MADE: 15-SEP-11 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATHASSIST LIGHT FIBER ENTELLUS MEDICAL, INC. 510(k) NO: K111763(TRADITIONAL) ATTN: KAREN E PETERSON PHONE NO : 763 463 7056 6705 WEDGWOOD COURT NORTH SE DECISION MADE: 15-SEP-11 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 STRPTOCOCCUS AMPICILLIN BIOMERIEUX, INC. 510(k) NO: K112075(TRADITIONAL) ATTN: JOLYN TENLLADO PHONE NO : 314 731 8386 595 ANGLUM RD. SE DECISION MADE: 15-SEP-11 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS APEX BIOTECHNOLOGY CORP. 510(k) NO: K102816(TRADITIONAL) ATTN: HSUE-MEI LEE PHONE NO : 886 356 41952 NO. 7, LI-HSIN ROAD V, HSINCHU SCISE DECISION MADE: 15-SEP-11 HSINCHU TW 30078 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: R4 ACERT ULTRASOUND REPORTING SYSTEM R4 LLC 510(k) NO: K101898(TRADITIONAL) ATTN: CRISTIAN NEGRILA PHONE NO : 440 546 4272 17999 FOLTZ PARKWAY SE DECISION MADE: 15-SEP-11 STRONGSVILLE OH 44149 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES MAQUET CARDIOPULMONARY AG 510(k) NO: K112360(SPECIAL) ATTN: KATRIN SCHWENKGLENKS PHONE NO : 497 478 921373 HECHINGER STRASSE 38 SE DECISION MADE: 15-SEP-11 HIRRLINGEN GM 72145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRAGET DETACHABLE COIL STRYKER NEUROVASCULAR 510(k) NO: K112385(SPECIAL) ATTN: JAMES LEATHLEY PHONE NO : 510 440 7836 47900 BAYSIDE PARKWAY SE DECISION MADE: 15-SEP-11 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE OTTO BOCK HEALTHCARE, LP 510(k) NO: K111278(TRADITIONAL) ATTN: WILLIAM KABITZ PHONE NO : 763 553 9464 TWO CARLSON PARKWAY NORTH SUITE 10SE DECISION MADE: 16-SEP-11 MINNEAPOLIS MN 55447 4467 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION CELLAVISION AB 510(k) NO: K102778(TRADITIONAL) ATTN: CONSTANCE G BUNDY PHONE NO : 763 574 1976 435 RICE CREEK TERRACE NE SE DECISION MADE: 16-SEP-11 FRIDLEY MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICAL MASKS SHANGHAI NEO-MEDICAL IMPORT & EXPO510(k) NO: K111559(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 21 64264468 P.O. BOX 237-023 SE DECISION MADE: 16-SEP-11 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS EV3 INC 510(k) NO: K111490(SPECIAL) ATTN: DANIEL CHER, MD PHONE NO : 650 566 0057 173 JEFFERSON DR SE DECISION MADE: 16-SEP-11 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEAUTISEALANT SHOFU DENTAL CORPORATION 510(k) NO: K111782(TRADITIONAL) ATTN: DAVID P MORAIS PHONE NO : 760 736 3277 1225 STONE DRIVE SE DECISION MADE: 16-SEP-11 SAN MARCOS CA 92078 510(k) STATEMENT DEVICE: ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K112596(TRADITIONAL) ATTN: SHELLY PEARCE PHONE NO : 650 694 5988 1230 SHOREBIRD WAY SE DECISION MADE: 16-SEP-11 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PERMASHADE VENEER CEMENT ULTRADENT PRODUCTS, INC. 510(k) NO: K111836(TRADITIONAL) ATTN: COREY JASEPH PHONE NO : 801 552 5512 505 WEST 10200 SOUTH SE DECISION MADE: 16-SEP-11 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVIAFIT FLOWMEDIC LTD. 510(k) NO: K111720(TRADITIONAL) ATTN: AHAVA STEIN PHONE NO : 972 976 70002 20 HATAAS STR. SUITE 102 SE DECISION MADE: 16-SEP-11 KFAR SABA IS 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. 510(k) NO: K111728(SPECIAL) ATTN: YC LEI PHONE NO : 886 366 86868 NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 16-SEP-11 HSINCHU CITY, HSINCHU TW 30077 510(k) STATEMENT DEVICE: NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) CARTICEPT MEDICAL INC 510(k) NO: K112067(TRADITIONAL) ATTN: TANYA EBERLE PHONE NO : 770 754 3814 6120 WINDWARD PRKWY SUITE 220 SE DECISION MADE: 16-SEP-11 ALPHARETTA GA 30005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOURNEY II BCS KNEE SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K111711(ABBREVIATED) ATTN: SHEREEN MYERS PHONE NO : 901 399 6325 7135 GOODLET FARMS PARKWAY SE DECISION MADE: 16-SEP-11 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICASSO/ PICASSO LITE/ PICASSO PERIO AMD LASERS, LLC 510(k) NO: K102359(ABBREVIATED) ATTN: AMY SZENTES PHONE NO : 317 202 9530 7405 WESTFIELD BLVD. SE DECISION MADE: 16-SEP-11 INDIANAPOLIS IN 46240 510(k) STATEMENT DEVICE: DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM DELBIO INCORPORATION 510(k) NO: K100806(TRADITIONAL) ATTN: NICKY PAN PHONE NO : 886 335 96268#8672 3F, NO. 252, SHANGYING ROAD GUISHASE DECISION MADE: 16-SEP-11 TAOYUAN COUNTY TW 33341 510(k) STATEMENT DEVICE: TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001 ENCORE MEDICAL, L.P. 510(k) NO: K111629(TRADITIONAL) ATTN: TEFFANY HUTTO PHONE NO : 512 834 6255 9800 METRIC BLVD. SE DECISION MADE: 16-SEP-11 AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S8 DIAGNOSTIC ULTRASOUND SYSTEM SONOSCAPE COMPANY LIMITED 510(k) NO: K112451(SPECIAL) ATTN: DIANA HONG PHONE NO : 821 228 15850 P.O. BOX 237-023 SE DECISION MADE: 16-SEP-11 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDLEN IMAGING - GEMINI DUSB EDLEN IMAGING LLC 510(k) NO: K103290(ABBREVIATED) ATTN: FELIX HOVSEPIAN PHONE NO : 602 524 9611 3707 N 7TH STREET SUITE 125 SE DECISION MADE: 19-SEP-11 PHOENIX AZ 85014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NXSTAGE PUREFLOW SL NXSTAGE MEDICAL, INC. 510(k) NO: K111174(SPECIAL) ATTN: MARY LOU STROUMBOS PHONE NO : 978 687 4872 439 SOUTH UNION ST., 5TH FLOOR SE DECISION MADE: 19-SEP-11 LAWRENCE MA 01843 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE BIONOSTICS, INC. 510(k) NO: K112356(TRADITIONAL) ATTN: RANDY BYRD PHONE NO : 978 772 7070 7 JACKSON RD. SE DECISION MADE: 19-SEP-11 DEVENS MA 01434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K112236(TRADITIONAL) ATTN: JOE SHIA PHONE NO : 240 505 7880 504 EAST DIAMOND AVE. SUITE F SE DECISION MADE: 19-SEP-11 GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOBILETT MIRA SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K111912(SPECIAL) ATTN: PATRICIA D JONES PHONE NO : 610 484 3536 51 VALLEY STREAM PKWY. SE DECISION MADE: 19-SEP-11 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 HILL-ROM CO. 510(k) NO: K112502(TRADITIONAL) ATTN: CHAD HODSON PHONE NO : 812 934 1278 1069 STATE RT. 46 EAST SE DECISION MADE: 19-SEP-11 BATESVILLE IN 47006 9167 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY IRIS MOLECULAR DIAGNOSTICS 510(k) NO: K101185(TRADITIONAL) ATTN: ROBERT KLEM PHONE NO : 760 438 9923 2075 CORTE DEL NOGAL SUITE J SE DECISION MADE: 20-SEP-11 CARLSBAD CA 92011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMSCO CHIMERON SMALL STEAM STERILIZER STERIS CORPORATION 510(k) NO: K111223(ABBREVIATED) ATTN: ROBERT F SULLIVAN PHONE NO : 440 392 7695 5960 HEISLEY ROAD SE DECISION MADE: 20-SEP-11 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM ZYNEX MEDICAL, INC. 510(k) NO: K111279(ABBREVIATED) ATTN: JIM ARNOLD PHONE NO : 303 703 4906 9990 PARK MEADOWS DR SE DECISION MADE: 20-SEP-11 LONE TREE CO 80124 510(k) STATEMENT DEVICE: TANDEMHEART PUMP CARDIACASSIST INC. 510(k) NO: K110493(TRADITIONAL) ATTN: ROBERT BOLLINGER PHONE NO : 412 963 7770 240 ALPHA DRIVE SE DECISION MADE: 20-SEP-11 PITTSBURGH PA 15238 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPACER-K, SPACER-G, SPACER-S TECRES SPA 510(k) NO: K101356(TRADITIONAL) ATTN: CHRISTINE BRAUER PHONE NO : 301 545 1990 7 TRAIL HOUSE COURT SE DECISION MADE: 20-SEP-11 ROCKVILLE MD 20850 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX MICROVENTION, INC. 510(k) NO: K111451(TRADITIONAL) ATTN: LARAINE PANGELINA PHONE NO : 714 247 8000 1311 VALENCIA AVE SE DECISION MADE: 20-SEP-11 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERALAS 147NM DIODE LASER SYSTEM BIOLITEC, INC. 510(k) NO: K112253(TRADITIONAL) ATTN: HARRY HAYES PHONE NO : 413 250 0779 1349 MAIN ROAD SE DECISION MADE: 20-SEP-11 GRANVILLE MA 01034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE MOLNLYCKE HEALTH CARE US, LLC 510(k) NO: K112257(SPECIAL) ATTN: ANGELA L BUNN PHONE NO : 678 250 7930 5550 PEACHTREE PARKWAY SUITE 500 SE DECISION MADE: 20-SEP-11 NORCROSS GA 30092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SORIN CENTRIFUGAL PUMP 5 (CP5) SORIN GROUP DEUTSCHLAND GMBH 510(k) NO: K112225(SPECIAL) ATTN: ROSINA ROBINSON PHONE NO : 508 643 0434 49 PLAIN STREET SE DECISION MADE: 20-SEP-11 NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NT 2000 LESIONING GENERATOR NEUROTHERM, INC. 510(k) NO: K111576(TRADITIONAL) ATTN: F. DAVID ROTHKOPF PHONE NO : 617 899 3449 200 HOMER AVE SE DECISION MADE: 20-SEP-11 ASHLAND MA 01721 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULL AUTO TONOMETER MODEL TX-20 CANON, INC.-MEDICAL EQUIPMENT GROU510(k) NO: K111710(SPECIAL) ATTN: KOJI KUBO PHONE NO : 81 42 5481253 C/O COSMOS CORPORATION 3F 2-17-6 ASE DECISION MADE: 20-SEP-11 TACHIKAWA-SHI, TOKYO JA 190-001510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM ROCHE DIAGNOSTICS 510(k) NO: K101299(TRADITIONAL) ATTN: ANDRENE HERON PHONE NO : 317 521 2150 9115 HAGUE ROAD SE DECISION MADE: 21-SEP-11 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K110061(ABBREVIATED) ATTN: ERNEST JOSEPH PHONE NO : 914 524 2431 511 BENEDICT AVENUE SE DECISION MADE: 21-SEP-11 TARRYTOWN NY 10591 5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM US DIAGNOSTICS, INC. 510(k) NO: K110435(SPECIAL) ATTN: JONATHAN JOHNSON PHONE NO : 646 454 5401 304 PARK AVENUE SOUTH SUITE 218 SE DECISION MADE: 21-SEP-11 NEW YORK NY 10010 4301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIPLE LUMEN PFM PICC PFM MEDICAL, INC 510(k) NO: K110914(TRADITIONAL) ATTN: SALVADORE PALOMARES PHONE NO : 760 758 8749 1815 ASTON AVE SUITE 106 SE DECISION MADE: 21-SEP-11 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE INMED GLOVES FACTORY 510(k) NO: K111857(TRADITIONAL) ATTN: XIAOBING LI PHONE NO : 865 362 197070 10-2 XING'AN RD. EAST, LINQU, SE DECISION MADE: 21-SEP-11 WEIFANG, SHANDONG CH 262600 510(k) STATEMENT DEVICE: VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET NUCLETRON 510(k) NO: K111973(SPECIAL) ATTN: MICHAEL PAUL PHONE NO : 443 545 2182 7021 COLUMBIA GATEWAY DR SUITE 200SE DECISION MADE: 21-SEP-11 Columbia MD 21046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING CARDINAL HEALTH-MEDICAL PRODUCTS A510(k) NO: K111868(TRADITIONAL) ATTN: TATYANA BOGDAN PHONE NO : 847 887 2325 1430 WAUKEGAN RD. SE DECISION MADE: 21-SEP-11 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRTUE DIAGNOSOFT, INC. 510(k) NO: K111833(TRADITIONAL) ATTN: JEFFREY ROBERTS PHONE NO : 508 643 0434 49 PLAIN STREET SE DECISION MADE: 21-SEP-11 NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CMS-1000FM CENTRAL MONITORING SYSTEM ADVANCED INSTRUMENTATIONS, INC. 510(k) NO: K112159(TRADITIONAL) ATTN: JORGE MILLAN PHONE NO : 305 925 1260 601 WEST 20 ST SE DECISION MADE: 21-SEP-11 HIALEAH FL 33010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FM-1000 PLUS FETAL MONITOR ADVANCED INSTRUMENTATIONS, INC. 510(k) NO: K112187(TRADITIONAL) ATTN: JORGE MILLAN PHONE NO : 305 925 1260 601 W 20 ST SE DECISION MADE: 21-SEP-11 HIALEAH FL 33010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD ORTHO DEVELOPMENT 510(k) NO: K111936(SPECIAL) ATTN: TOM HAUETER PHONE NO : 801 553 9991 12187 S. BUSINESS PARK DR. SE DECISION MADE: 21-SEP-11 DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Z BOND, PRELUDE ONE DANVILLE MATERIALS, INC. 510(k) NO: K111876(TRADITIONAL) ATTN: LINDSAY TILTON PHONE NO : 925 973 0710 3420 FOSTORIA WAY, SUITE A-200 SE DECISION MADE: 21-SEP-11 SAN RAMON CA 94583 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ODALYS PEDICLE SCREW SYSTEM KALITEC DIRECT, LLC 510(k) NO: K111370(TRADITIONAL) ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD SE DECISION MADE: 21-SEP-11 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORONIS FUSION 4MP DL BARCO NV 510(k) NO: K111989(SPECIAL) ATTN: LIEVEN DE WANDEL PHONE NO : 325 623 3459 35 PRESIDENT KENNEDYPARK SE DECISION MADE: 22-SEP-11 KORTRIJK BE 8500 510(k) STATEMENT DEVICE: OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT OSTEOSYMBIONICS, LLC 510(k) NO: K111069(TRADITIONAL) ATTN: ELAINE DUNCAN PHONE NO : 715 549 6035 P.O. BOX 560 SE DECISION MADE: 22-SEP-11 STILLWATER MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT RHYTHMLINK INTERNATIONAL, LLC 510(k) NO: K112435(SPECIAL) ATTN: JAMES MEWBORNE PHONE NO : 803 252 1222 1140 FIRST STREET SOUTH SE DECISION MADE: 22-SEP-11 COLUMBIA SC 29209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIFORCE LARGE MONITOR SYSTEM EIZO GMBH 510(k) NO: K112645(TRADITIONAL) ATTN: BERND HOMBERG PHONE NO : 497 212 0321220 SIEMENSALLEE 84 D-76187 SE DECISION MADE: 22-SEP-11 KARLSRUBE GM 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CORELEADER SCAR-DIMMER CORELEADER BIOTECH CO., LTD. 510(k) NO: K111733(TRADITIONAL) ATTN: IAN LI PHONE NO : 886 226 9688880 19F NO. 100, SEC 1 SINTAI 5TH RD, SE DECISION MADE: 22-SEP-11 NEW TAIPEI, TAIWAN TW 22102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSITITRE OPTIREAD TREK DIAGNOSTIC SYSTEMS, LTD. 510(k) NO: K110583(TRADITIONAL) ATTN: CYNTHIA C KNAPP PHONE NO : 216 351 8735 982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 22-SEP-11 CLEVELAND OH 44131 510(k) STATEMENT DEVICE: RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE VASCULAR PATHWAYS, INC. 510(k) NO: K112347(SPECIAL) ATTN: MICHAEL A DANIEL PHONE NO : 925 254 5228 8 SNOWBERRY COURT SE DECISION MADE: 22-SEP-11 ORINDA CA 94563 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 27 G X 1/2" K-PACK SURSHIELD NEEDLE TERUMO EUROPE N.V. 510(k) NO: K111797(SPECIAL) ATTN: M.J. AERTS PHONE NO : 320 163 81211 INTERLEUVENLAAN 40 SE DECISION MADE: 22-SEP-11 LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM ADVANCED INSTRUMENTATIONS, INC. 510(k) NO: K112022(TRADITIONAL) ATTN: JORGE MILLAN PHONE NO : 305 925 1260 601 WEST 20 ST SE DECISION MADE: 22-SEP-11 HIALEAH FL 33010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL ELECTROCARDIOGRAPH SHENZHEN BIOCARE ELECTRONICS CO., 510(k) NO: K112431(SPECIAL) ATTN: DIANA HONG PHONE NO : 86 212 2815850 P.O. BOX 237-023 SE DECISION MADE: 22-SEP-11 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES HOWMEDICA OSTEONICS CORP DBA STRYK510(k) NO: K112455(SPECIAL) ATTN: STEPHANIE FITTS PHONE NO : 201 831 5405 325 CORPORATE DRIVE SE DECISION MADE: 22-SEP-11 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PD-100 SERIES ULTRASONIC POCKET DOPPLER ADVANCED INSTRUMENTATIONS, INC. 510(k) NO: K111934(TRADITIONAL) ATTN: JORGE MILLAN PHONE NO : 305 925 1260 601 WEST 20 ST SE DECISION MADE: 22-SEP-11 HIALEAH FL 33010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULSIOFLEX PULSION MEDICAL SYSTEMS, INC. 510(k) NO: K112448(SPECIAL) ATTN: JAMIE SULLEY PHONE NO : 919 426 4023 1511 ESSEX RD SE DECISION MADE: 22-SEP-11 WESTBROOK CT 06498 510(k) STATEMENT DEVICE: MAMMODIAGNOST DR PHILIPS MEDICAL SYSTEMS 510(k) NO: K110572(TRADITIONAL) ATTN: LINDA JALBERT PHONE NO : 978 659 7434 3000 MINUTEMAN RD. SE DECISION MADE: 23-SEP-11 ANDOVER MA 01810 1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RHYTHMVIEW (TM) TOPERA, INC. 510(k) NO: K110878(TRADITIONAL) ATTN: RUCHIR SEHRA PHONE NO : 858 367 3395 11445 E. VIA LINDA SUITE 2, P.O. BSE DECISION MADE: 23-SEP-11 SCOTTSDALE AZ 85259 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK KIMBERLY-CLARK 510(k) NO: K103150(TRADITIONAL) ATTN: ANN WATERHOUSE PHONE NO : 678 352 6719 1400 HOLCOMB BRIDGE ROAD SUITE 115SE DECISION MADE: 23-SEP-11 ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY ENDOSCOPIC TECHNOLOGIES, INC. D/B/510(k) NO: K110913(SPECIAL) ATTN: TAMER IBRAHIM PHONE NO : 925 543 2110 2603 CAMINO RAMON SUITE 100 SE DECISION MADE: 23-SEP-11 SAN RAMON CA 94583 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: "UNITED" 36MM CERAMIC FEMORAL HEAD, DELTA UNITED ORTHOPEDIC CORPORATION 510(k) NO: K112463(SPECIAL) ATTN: FANG-YUAN HO PHONE NO : 886 357 73351 NO 57, PARK AVE 2, SCIENCE PARK SE DECISION MADE: 23-SEP-11 HSINCHU TW 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASEAL XT HYDRO ULTRADENT PRODUCTS, INC. 510(k) NO: K112517(SPECIAL) ATTN: DIANE ROGERS PHONE NO : 801 553 4491 505 WEST 10200 SOUTH SE DECISION MADE: 23-SEP-11 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORELEADER COLLA-ALGI FIBER MODEL CAW CORELEADER BIOTECH CO., LTD. 510(k) NO: K111578(TRADITIONAL) ATTN: IAN LI PHONE NO : 886 2 26968880 19F NO. 100, SEC 1 SINTAI 5TH RD, SE DECISION MADE: 23-SEP-11 TAIPEI, TAIWAN TW 22102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CS 7600 CARESTREAM HEALTH, INC. 510(k) NO: K111649(TRADITIONAL) ATTN: DANIEL HOEFER PHONE NO : 770 226 3287 1765 THE EXCHANGE SE DECISION MADE: 23-SEP-11 ATLANTA GA 30339 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMAGEM MOLECULAR BREAST IMAGING SYSTEM GAMMA MEDICA-IDEAS INCORPORATED 510(k) NO: K111791(TRADITIONAL) ATTN: ALBERT BONISKE PHONE NO : 408 400 0856 755 N. MATHILDA AVENUE SUITE 100 SE DECISION MADE: 23-SEP-11 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACQPOINT THERMAJADE MASSAGE TABLE ACQPOINT, INC. 510(k) NO: K102938(TRADITIONAL) ATTN: MORRIS SHEPPARD PHONE NO : 760 636 6811 79-825 HIGHWAY 111, SUITE 101 SE DECISION MADE: 23-SEP-11 LA QUINTA CA 92253 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K112071(TRADITIONAL) ATTN: JOE SHIA PHONE NO : 240 505 7880 504 EAST DIAMOND AVE. SUITE F SE DECISION MADE: 23-SEP-11 GAITHERSBRUG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLANMED NUANCE EXCEL PLANMECA USA, INC. 510(k) NO: K111361(TRADITIONAL) ATTN: BOB PIENKOWSKI PHONE NO : 630 529 2300 100 N. GARY AVE. SUITE A SE DECISION MADE: 23-SEP-11 ROSELLE IL 60172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS MASIMO CORPORATION 510(k) NO: K111888(SPECIAL) ATTN: ANIL BHALANI PHONE NO : 949 297 7000 40 AND 50 PARKER SE DECISION MADE: 23-SEP-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE CEDARS-SINAI MEDICAL CENTER 510(k) NO: K112474(SPECIAL) ATTN: GEOFF POLLARD PHONE NO : 310 423 4663 8700 BEVERLY BLVD SE DECISION MADE: 23-SEP-11 LOS ANGELES CA 90048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENUE 40 GE HEALTHCARE 510(k) NO: K112122(TRADITIONAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 INNOVATION DRIVE SE DECISION MADE: 23-SEP-11 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASS LP SPINAL SYSTEM MEDICREA INTERNATIONAL 510(k) NO: K110497(SPECIAL) ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD SE DECISION MADE: 26-SEP-11 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASTRA TECH IMPLANT SYSTEM ASTRA TECH AB 510(k) NO: K111287(TRADITIONAL) ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235 11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 26-SEP-11 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE KEPLER MEDTEC 510(k) NO: K110462(TRADITIONAL) ATTN: SHARYN ORTON, PHD PHONE NO : 401 330 8264 200 HOMER AVE SE DECISION MADE: 26-SEP-11 ASHLAND MA 01721 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEPHAFLEX MESH TEPHA, INC. 510(k) NO: K111946(TRADITIONAL) ATTN: MARY P LEGRAW PHONE NO : 781 357 1709 99 HAYDEN AVENUE, SUITE 360 SE DECISION MADE: 26-SEP-11 LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED ELECTROPHYSIOLOGY CATHETERS STRYKER SUSTAINABILITY SOLUTIONS 510(k) NO: K112232(TRADITIONAL) ATTN: AMANDA BABCOCK PHONE NO : 480 763 5376 5307 Great Oak Dr SE DECISION MADE: 26-SEP-11 LAKELAND FL 33815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INQU PASTE MIX ISTO TECHNOLOGIES, INC. 510(k) NO: K111838(TRADITIONAL) ATTN: PATSY J TRISLER PHONE NO : 301 652 5344 5600 WISCONSIN AVE. #509 SE DECISION MADE: 26-SEP-11 CHEVY CHASE MD 20815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELECTRA ACCESSORY KIT BIOTRONIK, INC. 510(k) NO: K111839(TRADITIONAL) ATTN: JON BRUMBAUGH PHONE NO : 888 345 0374 6024 JEAN ROAD SE DECISION MADE: 26-SEP-11 LAKE OSWEGO OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS BIOMATERIALS KOREA INC. 510(k) NO: K111809(SPECIAL) ATTN: KEVIN WALLS PHONE NO : 720 962 5412 5401 S. COTTONWOOD CT. SE DECISION MADE: 26-SEP-11 GREENWOOD VILLAGE CO 80121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HAIRMAX LASERCOMB LEXINGTON INTERNATIONAL, LLC 510(k) NO: K112524(SPECIAL) ATTN: DAVID MICHAELS PHONE NO : 561 314 2430 777 YAMATO RD., SUITE 105 SE DECISION MADE: 26-SEP-11 BOCA RATON FL 33431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE ESPINER SAC OR E SAC ESPINER MEDICAL LIMITED 510(k) NO: K111845(TRADITIONAL) ATTN: EDWIN LINDSAY PHONE NO : 004 479 17134922 116 ALMOND ROAD, CUMBERNAULD SE DECISION MADE: 26-SEP-11 GLASGOW UK G673LW 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE GE HEALTHCARE INTEGRATED IT SOLUTI510(k) NO: K111614(TRADITIONAL) ATTN: JEME WALLACE PHONE NO : 847 277 4468 540 W. NW HIGHWAY SE DECISION MADE: 26-SEP-11 BARRINGTON IL 60010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR TOTOKU ELECTRIC CO., LTD 510(k) NO: K111496(TRADITIONAL) ATTN: TSUKASA TASHIRO PHONE NO : 812 582 46611 300 OYA SE DECISION MADE: 26-SEP-11 UEDA, NAGANO JA 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE SPINEOLOGY INC. 510(k) NO: K111880(TRADITIONAL) ATTN: BRYAN BECKER PHONE NO : 651 256 8500 7800 THIRD STREET N. SUITE 600 SE DECISION MADE: 26-SEP-11 Saint Paul MN 55128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICASE ORTHOGNATHIC SOFTWARE WIZARD MATERIALISE N.V. 510(k) NO: K111641(TRADITIONAL) ATTN: OLIVER CLEMENS PHONE NO : 32 16 744537 TECHNOLOGIELAAN 15 SE DECISION MADE: 26-SEP-11 LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELECTRA SLITTER TOOL BIOTRONIK, INC. 510(k) NO: K112482(SPECIAL) ATTN: JON BRUMBAUGH PHONE NO : 888 345 0374 6024 JEAN ROAD SE DECISION MADE: 26-SEP-11 LAKE OSWEGO OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXETER HIP STEM HOWMEDICA OSTEONICS CORP 510(k) NO: K110290(TRADITIONAL) ATTN: VALERIE GIAMBANCO PHONE NO : 201 831 6275 325 CORPORATE DR. SE DECISION MADE: 27-SEP-11 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: META-LOCK SUTURE ANCHOR SYSTEM TARSUS MEDICAL INC. 510(k) NO: K110800(TRADITIONAL) ATTN: NICHOLAS MOURLAS PHONE NO : 650 237 0070 465 FAIRCHILD DRIVE SUITE 230 SE DECISION MADE: 27-SEP-11 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NMR LIPOPROFILE (R) TEST AND NMR PROFILER LIPOSCIENCE, INC 510(k) NO: K111516(TRADITIONAL) ATTN: SUZETTE M WARNER PHONE NO : 919 256 1326 2500 Sumner Blvd SE DECISION MADE: 27-SEP-11 Raleigh NC 27616 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOGIQ P3 GE HEALTHCARE 510(k) NO: K112371(TRADITIONAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 W. INNOVATION DRIVE SE DECISION MADE: 27-SEP-11 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIAL ARTERY COMPRESSION TOURNIQUET LEPU MEDICAL TECHNOLOGY (BEIJING) 510(k) NO: K111837(TRADITIONAL) ATTN: SHAN ZHAO PHONE NO : 861 080 120641 NO. 37 CHAOQIAN ROAD SE DECISION MADE: 27-SEP-11 BEIJING, CHANGPING DISTRICT CH 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K112555(SPECIAL) ATTN: CHRIS MCKEE PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 27-SEP-11 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K110673(TRADITIONAL) ATTN: DOUG THISTLETHWAITE PHONE NO : 330 425 1313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 27-SEP-11 TWINSBURG OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN BIOMERIEUX, INC. 510(k) NO: K112129(TRADITIONAL) ATTN: JOLYN TENLLADO PHONE NO : 314 731 8386 595 ANGLUM RD. SE DECISION MADE: 27-SEP-11 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION I-SENS, INC. 510(k) NO: K103396(SPECIAL) ATTN: STANLEY R GOODMAN PHONE NO : 516 227 2100 100 GARDEN CITY PLAZA, SITE 412B SE DECISION MADE: 27-SEP-11 GARDEN CITY NY 11530 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISOAMP HSV ASSAY BIOHELIX CORPORATION 510(k) NO: K111951(TRADITIONAL) ATTN: FRAN WHITE PHONE NO : 978 972 3808 32 TOZER RD SE DECISION MADE: 27-SEP-11 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONIX ULTRASOUND SCANNER ULTRASONIX MEDICAL CORPORATION 510(k) NO: K112726(TRADITIONAL) ATTN: CHAS YU PHONE NO : 604 279 8550 130-4311 VIKING WAY SE DECISION MADE: 27-SEP-11 RICHMOND, BRITISH COLUMBIA CA V510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM ABBOTT MEDICAL OPTICS INC 510(k) NO: K111697(ABBREVIATED) ATTN: OPHELIA BIGGS PHONE NO : 714 247 8614 1700 E. ST. ANDREW PLACE SE DECISION MADE: 27-SEP-11 SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LITE-MED LM-9200 ELMA LITE-MED INC 510(k) NO: K103217(ABBREVIATED) ATTN: WALT HSU PHONE NO : 886 229 154183 9TH FLOOR, 49 DONGXING ROAD XINYI SE DECISION MADE: 28-SEP-11 TAIPEI CITY TW 110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINEFRONTIER LUMBAR IBF SYSTEM SPINEFRONTIER, INC. 510(k) NO: K111553(ABBREVIATED) ATTN: HANNAH CROWE PHONE NO : 978 232 3990 500 CUMMINGS CENTER, STE. 3500 SE DECISION MADE: 28-SEP-11 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AURIGA XL STARMEDTEC GMBH 510(k) NO: K111475(TRADITIONAL) ATTN: GREGOR WEIDEMANN PHONE NO : 498 151 268610 KREUZSTRASSE 22 SE DECISION MADE: 28-SEP-11 STARNBERG GM 82319 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALINDROME H, SI, HSI CHRONIC CATHETER COVIDIEN 510(k) NO: K112477(SPECIAL) ATTN: WING NG PHONE NO : 508 261 6596 15 HAMPSHIRE STREET SE DECISION MADE: 28-SEP-11 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIONEER CROSSFUSE II IBF/VBR SYSTEM PIONEER SURGICAL TECHNOLOGY, INC. 510(k) NO: K112496(SPECIAL) ATTN: EMILY M DOWNS PHONE NO : 906 225 5602 375 RIVER PARK CIRCLE SE DECISION MADE: 28-SEP-11 MARQUETTE MI 49855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS HOWMEDICA OSTEONICS CORP 510(k) NO: K112556(SPECIAL) ATTN: VALERIE GIAMBANCO PHONE NO : 201 831 3275 325 CORPORATE DR. SE DECISION MADE: 28-SEP-11 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X12 STERILE RELFECTIVE MARKER SPHERE PINSCO INC. DBA B & L ENGINEERING 510(k) NO: K111443(TRADITIONAL) ATTN: LEE A BARNES PHONE NO : 714 505 9492 1901 CARNEGIE AVENUE SUITE Q SE DECISION MADE: 29-SEP-11 SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEODYNE DRESSING NEODYNE BIOSCIENCES, INC. 510(k) NO: K112131(TRADITIONAL) ATTN: PEGGY MCLAUGHLIN PHONE NO : 650 504 8501 127 INDEPENDENCE DRIVE SE DECISION MADE: 29-SEP-11 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCEPTER C OCCLUSION BALLOON CATHETER MICROVENTION, INC. 510(k) NO: K110741(TRADITIONAL) ATTN: NAOMI GONG PHONE NO : 714 247 8055 1311 VALENCIA AVE SE DECISION MADE: 29-SEP-11 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE M.V. S.R.L. 510(k) NO: K110606(TRADITIONAL) ATTN: ENRICO BISSON PHONE NO : 39 049 8630080 VIA MARZIA 9 SE DECISION MADE: 29-SEP-11 ABANO TERME PADOVA IT 35031 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR THAYER MEDICAL CORPORATION 510(k) NO: K111570(TRADITIONAL) ATTN: ERIKA S STRICKLAND PHONE NO : 520 790 5393 4575 SOUTH PALO VERDE Road SUITE 3SE DECISION MADE: 29-SEP-11 TUCSON AZ 85714 1961 510(k) STATEMENT DEVICE: MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM MEDICAM INC. 510(k) NO: K111350(TRADITIONAL) ATTN: PHILIPPE AMAR PHONE NO : 514 737 0404 7900 JEAN-BRILLON SE DECISION MADE: 29-SEP-11 MONTREAL, QUEBEC CA H8N 2L5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT INTUITIVE SURGICAL, INC. 510(k) NO: K112584(SPECIAL) ATTN: KIM T SERVANCE PHONE NO : 408 523 2100 950 KIFER RD. SE DECISION MADE: 29-SEP-11 SUNNYVALE CA 94086 5206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION BD MEDICAL SURGICAL 510(k) NO: K112434(TRADITIONAL) ATTN: JOHN ROBERTS PHONE NO : 201 847 5473 ONE BECTON DR. MC237 SE DECISION MADE: 29-SEP-11 FRANKLIN LAKES NJ 07417 1880 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EQUIMATRIX LUITPOLD PHARMACEUTICALS, INC. 510(k) NO: K111816(ABBREVIATED) ATTN: MARSHA SIMON PHONE NO : 610 650 4200 ONE LUITPOLD DR. P.O. BOX 9001 SE DECISION MADE: 29-SEP-11 SHIRLEY NY 11967 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS PAREXELINTERNATIONAL 510(k) NO: K112525(SPECIAL) ATTN: BARRY SALL PHONE NO : 781 434 4742 195 WEST STREET SE DECISION MADE: 29-SEP-11 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMG SYSTEM MYOTRONICS-NOROMED, INC. 510(k) NO: K111687(SPECIAL) ATTN: F. ADIB PHONE NO : 206 243 4214 5870 S. 194TH ST. SE DECISION MADE: 29-SEP-11 KENT WA 98032 2126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID HERAEUS KULZER, LLC 510(k) NO: K111832(TRADITIONAL) ATTN: CHERYL ZIMMERMAN PHONE NO : 574 299 5444 300 HERAEUS WAY SE DECISION MADE: 29-SEP-11 SOUTH BEND IN 46614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET US INFUSION DBA TRUECARE BIOMEDIX 510(k) NO: K111351(ABBREVIATED) ATTN: AARON COMPTON PHONE NO : 866 593 8444 2003 NW 79TH AVE. SE DECISION MADE: 29-SEP-11 MIAMI FL 33122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM CONFORMIS, INC. 510(k) NO: K111916(TRADITIONAL) ATTN: AMITA S SHAH PHONE NO : 781 345 9164 11 NORTH AVENUE SE DECISION MADE: 29-SEP-11 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE KUNSHAN JIEHONG NONWOVEN PRODUCT C510(k) NO: K112136(TRADITIONAL) ATTN: GLEN FEYE PHONE NO : 619 517 1762 1340 WEST PENNSYLVANIA AVE SE DECISION MADE: 29-SEP-11 SAN DIEGO CA 92103 510(k) STATEMENT DEVICE: PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES CARDINAL HEALTH, INC. 510(k) NO: K111878(TRADITIONAL) ATTN: TATYANA BOGDAN PHONE NO : 847 887 2325 1430 WAUKEGAN ROAD SE DECISION MADE: 29-SEP-11 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. 510(k) NO: K112226(SPECIAL) ATTN: LARAINE PANGELINA PHONE NO : 714 247 8150 1311 VALENCIA AVE SE DECISION MADE: 29-SEP-11 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AGILLS PF DELIVERY SYSTEM ST. JUDE MEDICAL, CARDIAC RHYTHM M510(k) NO: K111943(TRADITIONAL) ATTN: GEENA GEORGE PHONE NO : 818 493 2629 15900 VALLEY VIEW CT. SE DECISION MADE: 29-SEP-11 SYLMAR CA 91342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHARTIS CATHETER MODEL CHR-CA-12.0 PULMONX, INC. 510(k) NO: K111522(SPECIAL) ATTN: HANS SCHULZ PHONE NO : 650 364 0400 700 CHESAPEAKE DRIVE SE DECISION MADE: 29-SEP-11 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROVISION NERVE LOCATOR MONITOR NEUROVISION MEDICAL PRODUCTS, INC.510(k) NO: K110140(TRADITIONAL) ATTN: CHRISTINE VERGELY PHONE NO : 805 866 6999 2225 SPERRY AVE, SUITE 1000 SE DECISION MADE: 30-SEP-11 VENTURA CA 93003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 RANDOX LABORATORIES LIMITED 510(k) NO: K110846(TRADITIONAL) ATTN: PAULINE ARMSTRONG PHONE NO : 440 28 94422413 55 DIAMOND ROAD CRUMLIN SE DECISION MADE: 30-SEP-11 CRUMLIN ANTRIM UK BT29 4QY 510(k) STATEMENT DEVICE: DISCOVERY MR750W 3.0T GE HEALTHCARE JAPAN CORPORATION 510(k) NO: K103327(TRADITIONAL) ATTN: TORU SHIMIZU PHONE NO : 814 258 55344 7-127, ASAHIGAOKA 4-CHROME SE DECISION MADE: 30-SEP-11 HINO-SHI, TOKYO JA 191-8503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREERIDER MODEL LUGGIE MODEL 168-4IT FREERIDER LUGGIE SCOOTERS INC 510(k) NO: K110165(TRADITIONAL) ATTN: JEFFREY L DAVIS PHONE NO : 951 237 6192 4500 COUNTRY GLEN COURT SE DECISION MADE: 30-SEP-11 RIVERSIDE CA 92505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAPERLOC COMPLETE MICROPLASTY STEM BIOMET MANUFACTURING CORP. 510(k) NO: K110400(TRADITIONAL) ATTN: BECKY EARL PHONE NO : 574 267 6639 PO BOX 587 SE DECISION MADE: 30-SEP-11 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3 RANDOX LABORATORIES, LTD. 510(k) NO: K110904(TRADITIONAL) ATTN: PAULINE ARMSTRONG PHONE NO : 440 289 4422413 55 DIAMOND RD. SE DECISION MADE: 30-SEP-11 CRUMLIN, COUNTY ANTRIM UK BT29 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM PHADIA US INC. 510(k) NO: K102673(TRADITIONAL) ATTN: MARTIN M MANN PHONE NO : 269 492 1957 4169 COMMERCIAL AVE. SE DECISION MADE: 30-SEP-11 PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGIMAP (TM) SPINE NEMARIS INC 510(k) NO: K111019(TRADITIONAL) ATTN: KEITH A BARRITT PHONE NO : 202 783 5070 1425 K STREET N.W. 11TH FLOOR SE DECISION MADE: 30-SEP-11 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LDR SPINE ROI-A INTERBODY FUSION SYSTEM LDR SPINE USA 510(k) NO: K110327(SPECIAL) ATTN: MARITZA ELIAS PHONE NO : 512 344 3371 4030 WEST BRAKER LANE SUITE 360 SE DECISION MADE: 30-SEP-11 AUSTIN TX 78759 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS INTELLIVUE TCG10 PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K110474(ABBREVIATED) ATTN: JENS-PETER SEHER PHONE NO : 497 031 4632086 HEWLETT-PACKARD STR.2 SE DECISION MADE: 30-SEP-11 BOEBLINGEN GM D 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DESARA MESH CALDERA MEDICAL, INC. 510(k) NO: K112609(SPECIAL) ATTN: VICKI GAIL PHONE NO : 818 879 6555 5171 CLARETON DRIVE SE DECISION MADE: 30-SEP-11 AGOURA HILLS CA 91301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM BIOLITEC MEDICAL DEVICES, INC 510(k) NO: K112442(TRADITIONAL) ATTN: HARRY HAYES PHONE NO : 413 250 0779 1349 MAIN ROAD SE DECISION MADE: 30-SEP-11 GRANVILLE MA 01034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNAMIC ECG SYSTEM MODEL TLC5000 CONTEC MEDICAL SYSTEM CO., LTD. 510(k) NO: K101273(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 164 684973 SUITE 5D, NO. 19, LANE 999 ZHONGSHSE DECISION MADE: 30-SEP-11 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGELINK COMPUTER PROGRAMS AND SYSTEMS, INC510(k) NO: K112096(ABBREVIATED) ATTN: MICHAEL HUNT PHONE NO : 800 711 2774 6600 WALL STREET SE DECISION MADE: 30-SEP-11 MOBILE AL 36695 4512 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE ANDON MEDICAL CO., LTD. 510(k) NO: K112738(SPECIAL) ATTN: YI LIN PHONE NO : 86 22 87612426 NO.26 HANGYU RD. TIANJIN AIRPORT ESE DECISION MADE: 30-SEP-11 TIANJIN CH 300381 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HTS EXTREMITY COIL, HTS SURFACE COIL TIME MEDICAL SYSTEMS INC 510(k) NO: K112293(ABBREVIATED) ATTN: JOHN BABY PHONE NO : 852 215 61711 G/F, BIO-INFORMATICS CENTRE NO.2, SE DECISION MADE: 30-SEP-11 SHATIN, N.T., HONG KONG CH CH 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR HEALTH & LIFE CO., LTD. 510(k) NO: K112320(TRADITIONAL) ATTN: SARAH SU PHONE NO : 886 282 271300 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 30-SEP-11 CHUNG HO CITY, TAIPEI TW 235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX ELEKTA LIMITED 510(k) NO: K111676(TRADITIONAL) ATTN: PATRICK HULL PHONE NO : 441 293 544422 LINAC HOUSE, FLEMING WAY SE DECISION MADE: 30-SEP-11 CRAWLEY UK RH10 9RR 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K111865(TRADITIONAL) ATTN: DEBBIE PEACOCK PHONE NO : 203 602 3774 419 WEST AVE. SE DECISION MADE: 30-SEP-11 STAMFORD CT 06902 6300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM BECTON DICKINSON AND COMPANY (BD) 510(k) NO: K111366(TRADITIONAL) ATTN: RACHEL LEBLANC PHONE NO : 801 565 2649 9450 SOUTH STATE STREET SE DECISION MADE: 30-SEP-11 SANDY UT 84070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGISTEER SCISSORS, SURGISTEER DISSECTOR / GRASPER, SURGISTEER HOOK STEERABLE TECHNOLOGIX 510(k) NO: K111412(TRADITIONAL) ATTN: GLEN JORGENSEN PHONE NO : 904 641 2500 10302 Deerwood Park Blvd. Ste. 209SE DECISION MADE: 30-SEP-11 Jacksonville FL 32256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3DI INCLUDING CSCORE SHINA SYSTEMS LTD. 510(k) NO: K112530(TRADITIONAL) ATTN: DAN LAOR PHONE NO : 972 482 46632 6 SIRENI SE DECISION MADE: 30-SEP-11 HAIFA IS 32972 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 276 TOTAL WITH SUMMARIES 256 TOTAL WITH STATEMENTS 20
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