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U.S. Department of Health and Human Services

Medical Devices

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March 2011 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD March 2011


DEVICE: TROKAMED MORCELLATOR AND SHAVER
TROKAMED GMBH                     510(k) NO: K091010(TRADITIONAL)

ATTN: ANGELIKA SCHERP PHONE NO : 31 206 125626 AMSTEL 320-I SE DECISION MADE: 01-MAR-11 AMSTERDAM NL 1017AP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX ECSTASY (MDMA) ASSAY RANDOX LABORATORIES, LTD. 510(k) NO: K092275(TRADITIONAL)
ATTN: P. ARMSTRONG PHONE NO : 44 28 94422413 55 DIAMOND RD. SE DECISION MADE: 01-MAR-11 CRUMLIN, COUNTY ANTRIM UK BT29 510(k) STATEMENT DEVICE: V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K101569(TRADITIONAL)
ATTN: TELING HSU PHONE NO : 886 2 66258188 3F, 5F, NO 127 WUGONG 2ND RD WUGU SE DECISION MADE: 01-MAR-11 TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MSA HIP SYSTEM GLOBAL MANUFACTURING TECHNOLOGY 510(k) NO: K102172(TRADITIONAL)
ATTN: HOLLACE S RHODES PHONE NO : 202 552 5800 1331 H STREET NW SE DECISION MADE: 01-MAR-11 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES THD SPA 510(k) NO: K103647(SPECIAL)
ATTN: GUIDO BONAPACE PHONE NO : 393 355 378686 VIA BORGO SANTA CRISTINA 12 SE DECISION MADE: 01-MAR-11 IMOLA, BO IT 40026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STELLAR 150 RESMED GERMANY INC. 510(k) NO: K103167(TRADITIONAL)
ATTN: SANDRA GRUNWALD PHONE NO : 498 999 0100 FRAUNHOFERSTRASSE 16 SE DECISION MADE: 01-MAR-11 MUNCHEN GM D-82152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010 SHENZHEN BIOCARE ELECTRONICS CO., 510(k) NO: K101876(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467 SUITE 5D, NO 19, LANE 999 ZHONGSHASE DECISION MADE: 01-MAR-11 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGISURE TISSUE REMOVAL SYSTEM INTERLACE MEDICAL, INC. 510(k) NO: K103741(TRADITIONAL)
ATTN: JOHN J VOZELLA PHONE NO : 508 875 1343 135 NEWBURY STREET SE DECISION MADE: 02-MAR-11 FRAMINGHAM MA 01701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAGUNA PEDICLE SCREW SYSTEM PHYGEN, LLC 510(k) NO: K103748(TRADITIONAL)
ATTN: HARTMUT LOCH PHONE NO : 949 752 7785 2301 DUPONT DRIVE SUITE 510 SE DECISION MADE: 02-MAR-11 IRVINE CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONCORDE BULLET CAGE SYSTEM JOHNSON AND JOHNSON 510(k) NO: K103488(SPECIAL)
ATTN: KEVIN G STEVENS PHONE NO : 508 977 6445 325 PARAMOUNT DR. SE DECISION MADE: 02-MAR-11 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOOD PRESSURE CUFF APK TECHNOLOGY CO., LTD 510(k) NO: K102825(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 64264467 P.O. BOX 237-023 SE DECISION MADE: 02-MAR-11 SHANGHAI CH 518126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION SPACELABS HEALTHCARE LTD. 510(k) NO: K101850(TRADITIONAL)
ATTN: THOMAS KROENKE PHONE NO : 303 956 4232 PO BOX 3018 SE DECISION MADE: 02-MAR-11 NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPAULDING IQ ELECTROCARDIOGRAPH SPAULDING CLINICAL RESEARCH, LLC 510(k) NO: K110065(ABBREVIATED)
ATTN: PAUL SCHULTZ PHONE NO : 262 334 6020 525 S. SILVERBROOK DRIVE SE DECISION MADE: 02-MAR-11 WEST BEND WI 53095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INPECTRA STO2 SPOT CHECK HUTCHINSON TECHNOLOGY, INC. 510(k) NO: K103613(TRADITIONAL)
ATTN: COLIN M MCGRAW PHONE NO : 320 587 1926 40 WEST HIGHLAND PARK DR. NE SE DECISION MADE: 02-MAR-11 HUTCHINSON MN 55350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM SYNTHES (USA) 510(k) NO: K103002(TRADITIONAL)
ATTN: KARL J NITTINGER PHONE NO : 610 719 6941 1301 GOSHEN PKWY. SE DECISION MADE: 02-MAR-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES YTY INDUSTRY (MANJUNG) SDN. BHD. 510(k) NO: K101820(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775 342 2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 03-MAR-11 SPARKS NV 89434 9550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLINE ANGIOGRAPHIC CONTROL SYRINGE MEDLINE INDUSTRIES, INC. 510(k) NO: K093830(TRADITIONAL)
ATTN: MATT CLASEN PHONE NO : 847 643 4785 ONE MEDLINE PLACE SE DECISION MADE: 03-MAR-11 MUNDELEIN IL 60060 510(k) STATEMENT DEVICE: RESTORATION ACETABULAR WEDGE AUGMENTS HOWMEDICA OSTEONICS 510(k) NO: K102019(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201 831 5718 325 CORPORATE DRIVE SE DECISION MADE: 03-MAR-11 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TROPHON CHEMICAL INDICATOR NANOSONICS LIMITED 510(k) NO: K103126(TRADITIONAL)
ATTN: RON WEINBERGER PHONE NO : 612 806 31600 24/566 GARDENERS ROAD SE DECISION MADE: 03-MAR-11 ALEXANDRIA, NSW AS 2015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES AVITA CORPORATION 510(k) NO: K102554(SPECIAL)
ATTN: JENNIFER REICH PHONE NO : 928 863 8140 2904 N. BOLDT DR. SE DECISION MADE: 03-MAR-11 FLAGSTAFF AZ 86001 510(k) STATEMENT DEVICE: ZENITH PEDICLE SYSTEM APOLLO SPINE, INC. 510(k) NO: K102636(TRADITIONAL)
ATTN: CHRISTINE SANTAGATE PHONE NO : 781 828 4400 75 MILL STREET SE DECISION MADE: 03-MAR-11 STOUGHTON MA 02072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE TRAVERSE PLATE SYSTEM NUVASIVE, INC. 510(k) NO: K103750(SPECIAL)
ATTN: ELIAS KETCHUM PHONE NO : 858 320 4588 7475 LUSK BLVD SE DECISION MADE: 03-MAR-11 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL THE SEABERG COMPANY, INC. 510(k) NO: K102403(TRADITIONAL)
ATTN: JACK N MCCUTCHEON PHONE NO : 503 639 5474 4909 SOUTH COAST HWY., #245 SE DECISION MADE: 03-MAR-11 NEWPORT OR 97365 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANGUARD REMOVABLE MOLDED POLY TIBIA BIOMET MANUFACTURING CORP. 510(k) NO: K102580(TRADITIONAL)
ATTN: TAMARA J WEST PHONE NO : 574 371 3801 56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 03-MAR-11 WARSAW IN 46580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERLOCK FIBERED IDC OCCLUSION SYSTEM BOSTONSCIENTIFIC 510(k) NO: K102912(TRADITIONAL)
ATTN: DEBBIE MCINTIRE PHONE NO : 408 935 4679 ONE SCIMED PLACE SE DECISION MADE: 03-MAR-11 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPACELABS MULTI-PARAMETER MODULE SPACELABS HEALTHCARE, INC. 510(k) NO: K103142(SPECIAL)
ATTN: THOMAS KROENKE PHONE NO : 303 956 4232 PO BOX 3018 SE DECISION MADE: 03-MAR-11 NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM BOSTON SCIENTIFIC CORP. 510(k) NO: K110295(SPECIAL)
ATTN: SHANNON PETTIT PHONE NO : 763 494 2833 ONE SCIMED PLACE SE DECISION MADE: 03-MAR-11 MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXIS PACS, HMS PACS AXIS HEALTH CARE, LLC 510(k) NO: K103679(TRADITIONAL)
ATTN: RONALD W GRAHAM PHONE NO : 334 279 9711 5755 CARMICHAEL PARKWAY SE DECISION MADE: 03-MAR-11 MONTGOMERY AL 36117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERMOBIL M300 / M400 PERMOBIL AB 510(k) NO: K103477(TRADITIONAL)
ATTN: JAN ASTROM PHONE NO : 466 059 5959 BOX 120 SE DECISION MADE: 03-MAR-11 TIMRA SW S-861 23 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ-MISTER N.M. BEALE CO. INC. 510(k) NO: K093584(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978 772 3552 5 WHITCOMB AVENUE SE DECISION MADE: 04-MAR-11 AYER MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICRO SONOSCAPE COMPANY LIMITED 510(k) NO: K102642(TRADITIONAL)
ATTN: MIN YAO PHONE NO : 925 556 1302 30251 CEDARBROOK ROAD SE DECISION MADE: 04-MAR-11 HAYWARD CA 94544 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNAPSE 3D CEREBRAL ANALYSIS FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K103687(TRADITIONAL)
ATTN: DEBBIE PEACOCK PHONE NO : 203 602 3774 419 WEST AVE. SE DECISION MADE: 04-MAR-11 STAMFORD CT 06902 6300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNITED CERAMIC FEMORAL HEAD, DELTA UNITED ORTHOPEDIC CORP. 510(k) NO: K103497(TRADITIONAL) ATTN: FANG-YUAN HO PHONE NO : 886 357 73351 57 PARK AVE. 2, SCIENCE PARK SE DECISION MADE: 04-MAR-11 HSINCHU TW 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOCUS EMG DEVICE TELEEMG, LLC USA 510(k) NO: K102610(TRADITIONAL)
ATTN: JOE F JABRE, M.D. PHONE NO : 617 840 3253 65 ARLINGTON ROAD SE DECISION MADE: 04-MAR-11 WOBURN MA 01801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM SYNTHES USA 510(k) NO: K110354(SPECIAL)
ATTN: THOMAS N SHEA PHONE NO : 610 719 6809 1301 GOSHEN PKWY SE DECISION MADE: 04-MAR-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W EKF-DIAGNOSTIC GMBH 510(k) NO: K110393(SPECIAL)
ATTN: STEPHEN GORSKI PHONE NO : 262 594 2114 S65 W35739 PIPER ROAD SE DECISION MADE: 04-MAR-11 EAGLE WI 53119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIEWPOINT 6 GE HEALTHCARE 510(k) NO: K103458(TRADITIONAL)
ATTN: NICOLE LANDREVILLE PHONE NO : 289 208 2365 3000 NORTH GRANDVIEW BLVD #W450 SE DECISION MADE: 04-MAR-11 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR BIOMET, INC. 510(k) NO: K110145(TRADITIONAL)
ATTN: ELIZABETH WRAY PHONE NO : 574 371 1176 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 04-MAR-11 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAUMEDIC- ICP-MONITORING SYSTEM RAUMEDIC AG 510(k) NO: K103206(TRADITIONAL)
ATTN: REINER THIEM PHONE NO : 004 992 523592782 HERRMANN-STAUDINGER-STR. 2 SE DECISION MADE: 04-MAR-11 HELMBRECHTS GM D 95233 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OLECRA INTRAMEDULLARY FIXATION SYSTEM MYLAD ORTHOPEDIC SOLUTIONS 510(k) NO: K110322(SPECIAL)
ATTN: SCOTT G EDWARDS PHONE NO : 877 876 9523 8803 WINDY CREEK WAY SE DECISION MADE: 04-MAR-11 MCLEAN VA 22102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIO TRAUMA SPINAL SYSTEM STRYKER CORPORATION 510(k) NO: K103292(TRADITIONAL)
ATTN: CURTIS TRUESDALE PHONE NO : 201 760 8029 2 PEARL COURT SE DECISION MADE: 04-MAR-11 ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULMOTRACK 2020 SYSTEM KARMELSONIX 510(k) NO: K102229(SPECIAL)
ATTN: YORAM LEVY PHONE NO : 972 463 88837 31 HAAVODA ST. SE DECISION MADE: 04-MAR-11 BINYAMINA IS 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARCO MAMMO TOMOSYNTHESIS BARCOVIEW, MEDICAL IMAGING SYSTEMS510(k) NO: K103792(TRADITIONAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 325 623 3211 35 PRESIDENT KENNEDYPARK SE DECISION MADE: 04-MAR-11 KORTRIJK BE B-8500 510(k) STATEMENT DEVICE: FLAATZ 750E DRTECH CORP. 510(k) NO: K102474(TRADITIONAL) ATTN: BEOM-JIN MOON PHONE NO : 823 178 87653 333-1, SANGDEAWON 1-DONG JUNGWON-GSE DECISION MADE: 04-MAR-11 SEONGNAM-SHI, GYEONGGI-DO KS 46510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARIETEX PROGRIP SOFRADIM PRODUCTION 510(k) NO: K103682(SPECIAL)
ATTN: JAMES MCMAHON PHONE NO : 781 839 1787 15 CROSBY DRIVE SE DECISION MADE: 04-MAR-11 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING MAQUET CARDIOPULMONARY AG 510(k) NO: K102464(TRADITIONAL)
ATTN: KATRIN SCHWENKGLENKS PHONE NO : 49 747 89210 HECHINGER STRASSE 38 SE DECISION MADE: 04-MAR-11 HIRRLINGEN GM 72145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMATOM DEFINITION AS SIEMENS MEDICAL SOLUTIONS USA INC.510(k) NO: K103127(TRADITIONAL)
ATTN: ALICIA BUSTOS-JUERGENSEN PHONE NO : 610 448 4056 51 VALLEY STREAM PARKWAY SE DECISION MADE: 04-MAR-11 MALVERN PA 19355 1406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7) DAESUNG MAREF CO., LTD. 510(k) NO: K102320(TRADITIONAL)
ATTN: BRANDON CHOI PHONE NO : 714 523 1592 49 CANDLEWOOD WAY SE DECISION MADE: 04-MAR-11 BUENA PARK CA 90621 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP HARRY J. BOSWORTH CO. 510(k) NO: K103585(TRADITIONAL)
ATTN: GARY CHUVEN PHONE NO : 847 679 3400 7227 NORTH HAMLIN AVE. SE DECISION MADE: 04-MAR-11 SKOKIE IL 60076 510(k) STATEMENT DEVICE: STERRAD 100NX STERILIZER EXPRESS CYCLE ADVANCED STERILIZATION PRODUCTS 510(k) NO: K092622(TRADITIONAL)
ATTN: NANCY CHU PHONE NO : 949 453 6435 33 TECHNOLOGY DR. SE DECISION MADE: 04-MAR-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRO DIARY SPIROMETER VIASYS RESPIRATORY CARE INC. 510(k) NO: K100928(TRADITIONAL)
ATTN: MERRITT GIRGIS PHONE NO : 714 919 3286 22745 SAVI RANCH PKWY. SE DECISION MADE: 07-MAR-11 YORBA LINDA CA 92887 4645 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES GIVEN IMAGING LTD. 510(k) NO: K101250(TRADITIONAL)
ATTN: TIM THOMAS PHONE NO : 972 490 97936 NEW INDUSTRIAL PARK P.O. BOX 258 SE DECISION MADE: 07-MAR-11 YOQNEAM IS 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K101854(TRADITIONAL)
ATTN: KIRA GORDON PHONE NO : 914 524 2996 511 BENEDICT AVENUE SE DECISION MADE: 07-MAR-11 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLUOROMAP SOFTWARE, 9" FLUORODISC (BELT), 12" FLUORO DISC (BELT), CLOSE TUBE CLIP STRYKER CORPORATION 510(k) NO: K103400(TRADITIONAL)
ATTN: LILIAN ECKERT PHONE NO : 497 614 512117 BOETZINGER STR. 41 SE DECISION MADE: 07-MAR-11 FREIBURG GM 79111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAHI GUIDE WIRE EXTENSION 165CM ASAHI INTECC CO., LTD. 510(k) NO: K101985(SPECIAL)
ATTN: YOSHI TERAI PHONE NO : 949 756 8252 2500 RED HILL SUITE 210 SE DECISION MADE: 07-MAR-11 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALLA M SPINAL SYSTEM KOREA BONE BANK CO., LTD 510(k) NO: K102574(TRADITIONAL)
ATTN: JOYCE BANG PHONE NO : 714 525 0114 325 N PUENTE ST UNIT B SE DECISION MADE: 07-MAR-11 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEM OPTION FOR 1.5 MRI SYSTEMS GE HEALTHCARE 510(k) NO: K103335(TRADITIONAL)
ATTN: MICHAEL S PRETO PHONE NO : 330 995 8333 1515 DANNER DR. SE DECISION MADE: 07-MAR-11 AURORA OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THORACIC VCAR GE MEDICAL SYSTEMS, LLC 510(k) NO: K103480(TRADITIONAL)
ATTN: STEPHEN SLAVENS PHONE NO : 262 548 4992 3000 N GRANDVIEW SE DECISION MADE: 07-MAR-11 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYMMETRIC TOTAL KNEE AGUMENTS SIGNAL MEDICAL CORP. 510(k) NO: K100370(TRADITIONAL)
ATTN: BRIAN KATERBERG PHONE NO : 314 775 0518 1000 DES PERES ROAD SUITE 140 SE DECISION MADE: 07-MAR-11 ST. LOUIS MO 63131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTUM SPINAL SYSTEM, QUANTUM MIS PIONEER SURGICAL TECHNOLOGY 510(k) NO: K101790(TRADITIONAL)
ATTN: BARRY E SANDS PHONE NO : 978 363 5277 5 HEMINGWAY LANE SE DECISION MADE: 07-MAR-11 WEST NEWBURY MA 01985 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD FACS SAMPLE PREP ASSISTANT III (SPA III) BECTON DICKINSON & CO. 510(k) NO: K102064(TRADITIONAL)
ATTN: KATY CAMPBELL PHONE NO : 408 518 5066 2350 QUME DRIVE SE DECISION MADE: 07-MAR-11 SAN JOSE CA 95131 1807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EU-TTG IGA AND EU-TTG IGG GRIFOLS USA, INC. 510(k) NO: K102964(TRADITIONAL)
ATTN: CATHERINE L WONG PHONE NO : 323 227 7280 2410 LILLYVALE AVENUE SE DECISION MADE: 07-MAR-11 LOS ANGELES CA 90032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALEUTTIAN K2M, INC. 510(k) NO: K103169(SPECIAL)
ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR.,SE SE DECISION MADE: 07-MAR-11 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPL THERAPY SYSTEM BEIJING STARLIGHT SCIENCE & TECHNO510(k) NO: K101901(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467 SUITE 5D NO. 19 LANE 999 ZHONGSHANSE DECISION MADE: 08-MAR-11 SHANGHAI SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K110361(SPECIAL)
ATTN: EILEEN M BOYLE PHONE NO : 978 421 9171 269 MILL ROAD SE DECISION MADE: 08-MAR-11 CHELMSFORD MA 01824 4105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING MAQUET CARDIOPULMONARY AG 510(k) NO: K103191(TRADITIONAL)
ATTN: KATRIN SCHWENKGLENKS PHONE NO : 497 478 9210 HECHINGER STRASSE 38 SE DECISION MADE: 08-MAR-11 HIRRLINGEN GM 72145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRINITY ACETABULAR SYSTEM CORIN U.S.A. 510(k) NO: K103518(TRADITIONAL)
ATTN: LUCINDA GERBER, BA (HONS) PHONE NO : 813 977 4469 10500 UNIVERSITY CENTER DR., SUITESE DECISION MADE: 09-MAR-11 TAMPA FL 33612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOLUSON S6, VOLUSON S8 GE HEALTHCARE 510(k) NO: K103649(TRADITIONAL)
ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 INNOVATION DRIVE SE DECISION MADE: 09-MAR-11 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYSIS FORTH PHOTONICS HELLAS SA 510(k) NO: K092433(TRADITIONAL)
ATTN: JUAN CARLOS SERNA PHONE NO : 781 329 2993 690 CANTON ST, SUITE 302 SE DECISION MADE: 10-MAR-11 WESTWOOD MA 02090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY CORAIL HIP SYSTEM, REVISION STEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K093736(TRADITIONAL)
ATTN: RHONDA MYER PHONE NO : 574 371 4927 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 10-MAR-11 WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASY CUFF JOAN SPIEGEL, MD 510(k) NO: K102704(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSTAGE DR. SE DECISION MADE: 10-MAR-11 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIFY 270FP CHALLENGE PACK STERIS CORPORATION 510(k) NO: K103053(ABBREVIATED)
ATTN: ROBERT SULLIVAN PHONE NO : 440 392 7695 5960 HEISLEY ROAD SE DECISION MADE: 10-MAR-11 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIRSTRIP REMOTE PATIENT MONITORING (RPM) AIRSTRIP TECHNOLOGIES, LP 510(k) NO: K110503(SPECIAL)
ATTN: ANDY MILLER PHONE NO : 210 805 0444 3303 OAKWELL CT., SUITE 120 SE DECISION MADE: 10-MAR-11 SAN ANTONIO TX 78218 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: CERACELL DENTAL CURASAN AG 510(k) NO: K103709(ABBREVIATED)
ATTN: ROGER GRAY PHONE NO : 039 065 782665 PIAZZA ALBANIA, 10 SE DECISION MADE: 10-MAR-11 ROME IT 00153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ET III SA ULTRA WIDE SYSTEM HIOSSEN INC. 510(k) NO: K103537(SPECIAL)
ATTN: PATRICK LIM PHONE NO : 888 678 0001 85 BEN FAIRLESS DRIVE SE DECISION MADE: 10-MAR-11 FAIRLESS HILLS PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES) MICRO-MEGA SOCIETE ANONYME 510(k) NO: K103123(TRADITIONAL)
ATTN: CONCHE PHILIPPE PHONE NO : 333 815 44229 5-12 RUE DU TUNNEL SE DECISION MADE: 10-MAR-11 CEDEX BESANCON FR 25006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVEL TAPERED HIP STEM STRYKER CORP 510(k) NO: K103479(TRADITIONAL)
ATTN: ESTELA CELI PHONE NO : 201 831 6461 325 CORPORATE DRIVE SE DECISION MADE: 10-MAR-11 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERIT EMBOLECTOMY CATHETER MODEL ASAP100 MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K100569(TRADITIONAL)
ATTN: LINDSAY MARTIN PHONE NO : 801 208 4187 1600 WEST MERIT PKWY. SE DECISION MADE: 11-MAR-11 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINA XCISE MODEL MOR-1515 LINA MEDICAL APS 510(k) NO: K101458(TRADITIONAL)
ATTN: WALT BRITTLE PHONE NO : 919 942 1634 1289 N. FORDHAM BLVD. SUITE A-128 SE DECISION MADE: 11-MAR-11 CHAPEL HILL NC 27517 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS BIOMET 3I, INC. 510(k) NO: K101607(TRADITIONAL)
ATTN: JOSE E CABRERA PHONE NO : 561 776 6840 4555 RIVERSIDE DR. SE DECISION MADE: 11-MAR-11 PALM BEACH GARDENS FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS BIOMET 3I, INC. 510(k) NO: K101608(TRADITIONAL)
ATTN: JOSE E CABRERA PHONE NO : 561 776 6840 4555 RIVERSIDE DR. SE DECISION MADE: 11-MAR-11 PALM BEACH GARDENS FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISCOVRED PHOENIX DENTAL, INC. 510(k) NO: K102821(TRADITIONAL)
ATTN: JEFFREY S COX PHONE NO : 877 463 9905 3452 WEST THOMPSON RD. SE DECISION MADE: 11-MAR-11 FENTON MI 48430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIDA DIAGNOSTIC ULTRASOUND SYSTEM PANASONIC HEALTHCARE CO., LTD. 510(k) NO: K103148(TRADITIONAL)
ATTN: RAM BEDI PHONE NO : 425 985 8670 2425 SQUAK MOUNTAIN LOOP SW SE DECISION MADE: 11-MAR-11 ISSAQUAH WA 98027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO HANGZHOU JINCHENG MEDICAL SUPPLIER510(k) NO: K102692(TRADITIONAL)
ATTN: CHENGYU SHEN PHONE NO : 608 217 9358 5 CAREY STREET SE DECISION MADE: 11-MAR-11 PENNINGTON NJ 08534 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH CO., LTD. 510(k) NO: K102102(TRADITIONAL) ATTN: DAVE KIM PHONE NO : 832 623 2099 333 MEADOWLANDS PARKWAY, #303 SE DECISION MADE: 11-MAR-11 SECACUS NJ 07094 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NP15 WEINMANN GERATE FUR MEDIZIN GMBH +510(k) NO: K102515(TRADITIONAL)
ATTN: RALF EGENOLF PHONE NO : 011 49 4054702370 KRONSAALSWEG 40 SE DECISION MADE: 11-MAR-11 HAMBURG GM 22525 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STEALTH 360 ORBITAL PAD SYSTEM CARDIOVASCULAR SYSTEMS, INC. 510(k) NO: K110389(SPECIAL)
ATTN: MEGAN M BRANDT PHONE NO : 651 259 2805 651 CAMPUS DR SE DECISION MADE: 11-MAR-11 SAINT PAUL MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP MAYBORN BABY AND CHILD / JACKEL IN510(k) NO: K110343(TRADITIONAL)
ATTN: NEIL HEWITT PHONE NO : 441 912 501864 NORTHUMBERLAND BUSINESS PARK W SE DECISION MADE: 11-MAR-11 CRAMLINGTON, NORTHUMBERLAND UK 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CIV-OB (PLUS) CIVNET COMMUNICATION LTD 510(k) NO: K103172(TRADITIONAL)
ATTN: NATHAN BEN-NATHAN PHONE NO : 972 375 68824 Hatamar 58 SE DECISION MADE: 11-MAR-11 Moshav Hemed IS 50295 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STELLAR 300 LARSEN & TOUBRO LIMITED 510(k) NO: K103763(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 888 729 9674 1468 HARWELL AVE. SE DECISION MADE: 11-MAR-11 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E4D COMPASS D4D TECHNOLOGIES 510(k) NO: K110511(TRADITIONAL) ATTN: ALLISON SCOTT PHONE NO : 317 569 9500 11460 N MERIDIAN ST SUITE 150 SE DECISION MADE: 11-MAR-11 CARMEL IN 46032 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: COUDE/ OR TIEMANN DEGANIA SILICONE, LTD. 510(k) NO: K103371(TRADITIONAL)
ATTN: ZOYA LEE PHONE NO : 972 467 55122 DEGANIA BET SE DECISION MADE: 11-MAR-11 EMEK HAYARDEN IS 15130 510(k) STATEMENT DEVICE: GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K103712(TRADITIONAL)
ATTN: KRISTINE CHRISTO PHONE NO : 508 977 3359 325 PARAMOUNT DR. SE DECISION MADE: 11-MAR-11 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUKUDA DENSHI FUKUDA DENSHI USA, INC. 510(k) NO: K103134(TRADITIONAL)
ATTN: DOUG BLAKELY PHONE NO : 425 881 7737 17725 N.E. 65TH ST., BLDG. C SE DECISION MADE: 11-MAR-11 REDMOND WA 98052 4911 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISOGRAY TREATMENT PLANNING SYSTEM DOSISOFT SA 510(k) NO: K103146(TRADITIONAL) ATTN: ROBERT J MORTON PHONE NO : 925 787 2421 1244 FAIRWAY VALLEY COURT SE DECISION MADE: 11-MAR-11 LINCOLN CA 95648 8489 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM ANTHOGYR SAS 510(k) NO: K101913(ABBREVIATED)
ATTN: ERIC GENEVE PHONE NO : 330 450 580237 2237, AVENUE ANDRE LASQUIN SE DECISION MADE: 11-MAR-11 SALLANCHES FR 74700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEAD FIATION DEVICE (HFD 100) IMRIS, INC. 510(k) NO: K103493(TRADITIONAL)
ATTN: THOMAS M TSKERIS PHONE NO : 301 330 2076 16809 BRIARDALE ROAD SE DECISION MADE: 11-MAR-11 ROCKVILLE MD 20855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE MAQUET CARDIOPULMONARY AG 510(k) NO: K102919(TRADITIONAL)
ATTN: KATRIN SCHWENKGLENKS PHONE NO : 011 497 4789210 HECHINGER STRASSE 38 SE DECISION MADE: 11-MAR-11 HIRRLINGEN GM 72145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STCC CARDINAL SPINE, LLC 510(k) NO: K100698(TRADITIONAL)
ATTN: DAVID J COLLETTE PHONE NO : 858 792 1235 11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 14-MAR-11 SAN DIEGO CA 9213 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 FOSHAN CARE MEDICAL TECHNOLOGY CO.510(k) NO: K101552(TRADITIONAL)
ATTN: S.DAVID PIPER, PE PHONE NO : 916 483 3687 4807 EL CAMINO AVE STE C SE DECISION MADE: 14-MAR-11 CARMICHAEL CA 95608 510(k) STATEMENT DEVICE: NEWFIX EXTERNAL FIXATION SYSTEM TECHNOLOGIA Y DISENO INDUSTRIAL, S510(k) NO: K101338(TRADITIONAL)
ATTN: ROBERT BARD PHONE NO : 248 573 5040 PO BOX 506 SE DECISION MADE: 14-MAR-11 SOUTH LYON MI 48178 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V.A.C. VERAFLO CLEANSE DRESSING SYSTEM KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K103156(SPECIAL)
ATTN: MARGARET MARSH PHONE NO : 210 255 6481 6203 FARINON DRIVE SE DECISION MADE: 14-MAR-11 SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANS1 AXIALIF PLUS TRANS1 INCORPORATED 510(k) NO: K102334(TRADITIONAL)
ATTN: CHERYL WAGONER PHONE NO : 910 332 1703 301 GOVERNMENT CENTER DRIVE SE DECISION MADE: 14-MAR-11 WILMINGTON NC 28412 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSPRAY SYLC CR OSSPRAY LTD 510(k) NO: K103114(TRADITIONAL)
ATTN: IAN THOMPSON PHONE NO : 440 207 1884341 HODGKIN BUILDING KINGS COLLEGE LONSE DECISION MADE: 14-MAR-11 LONDON UK SE1 1UL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILVER ANTIMICROBIAL WOUND GEL ADVANCED MEDICAL SOLUTIONS LIMITED510(k) NO: K110458(SPECIAL)
ATTN: CLAIRE RYAN PHONE NO : 440 160 6863500 PREMIER PARK, 33 ROAD ONE, WINSFORSE DECISION MADE: 14-MAR-11 WINSFORD CHESHIRE UK CW7 3PD 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UBM PLUS ACCUTOME, INC. 510(k) NO: K103471(TRADITIONAL)
ATTN: BRIAN T.S. BARRETT PHONE NO : 610 889 0200 3222 PHOENIXVILLE PIKE SE DECISION MADE: 14-MAR-11 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ECHO BLASTER TELEMED 510(k) NO: K102253(TRADITIONAL)
ATTN: YURY SOKOLOV PHONE NO : 370 5 2106272 DARIARUS IR GIRENO STREET 42 SE DECISION MADE: 14-MAR-11 VILNIUS LH LT-02189 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SPIDER STANDARD AND ADVANCED TRANSENTERIX, INC. 510(k) NO: K102839(SPECIAL)
ATTN: BOBBI L HADERSBECK PHONE NO : 919 765 8400 635 DAVIS DRIVE SUITE 300 SE DECISION MADE: 15-MAR-11 MORRISVILLE NC 27560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALLERGEAZE R CLEAR SMARTPRACTICE 510(k) NO: K103409(TRADITIONAL)
ATTN: KIM SULLIVAN PHONE NO : 602 225 0595 3400 EAST MCDOWLL ROAD SE DECISION MADE: 15-MAR-11 PHOENIX AZ 85008 510(k) STATEMENT DEVICE: STAR 50 N LARSEN & TOUBRO LIMITED 510(k) NO: K103686(TRADITIONAL)
ATTN: E. J SMITH PHONE NO : 888 729 9674 1468 HARWELL AVE. SE DECISION MADE: 15-MAR-11 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY ATTUNE TOTAL KNEE SYSTEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K103756(TRADITIONAL)
ATTN: NANCY FRIDDLE PHONE NO : 574 371 4923 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 15-MAR-11 WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESSENTIAL MRI PATIENT MONITOR INVIVO CORPORATION 510(k) NO: K103700(SPECIAL)
ATTN: RUSTY KELLY PHONE NO : 407 455 6166 12151 RESEARCH PKWY SE DECISION MADE: 15-MAR-11 ORLANDO FL 32826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEMOMETAL NAVIS BONE PLATING SYSTEM MEMOMETAL TECHNOLOGIES 510(k) NO: K101930(TRADITIONAL)
ATTN: GILES AUDIC PHONE NO : 33 2 99055969 RUE BLAISE PASCAL CAMPUS DE KER LASE DECISION MADE: 15-MAR-11 BRUZ FR 35170 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO., LTD 510(k) NO: K110018(SPECIAL)
ATTN: LIU YI PHONE NO : 862 260 526161 No. 3 Jin Ping Street,Ya An Ro NANSE DECISION MADE: 15-MAR-11 TIANJIN CN 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BELIMED STEAM STERILIZER MST-V SAUTER AG 510(k) NO: K103841(ABBREVIATED)
ATTN: HANS STADLER PHONE NO : 004 171 6448500 ZELGSTRASSE 8 SE DECISION MADE: 15-MAR-11 SULGEN TG SZ CH-8583 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SINGLE CANNULA EXTENDED APPLICATOR MICROMEDICS, INC. 510(k) NO: K102563(TRADITIONAL)
ATTN: TOM LOPAC PHONE NO : 651 452 1977 1270 EAGAN INDUSTRIAL ROAD SE DECISION MADE: 15-MAR-11 ST PAUL MN 55121 1385 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANA0TOMICAL SHOULDER TM COMBINED SYSTEM ZIMMER GMBH 510(k) NO: K103404(TRADITIONAL)
ATTN: JASON HECKAMAN PHONE NO : 574 371 8675 P.O. BOX 708 SE DECISION MADE: 15-MAR-11 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALTUM ANTERIOR CERVICAL PLATE SPINECRAFT LLC 510(k) NO: K103505(TRADITIONAL)
ATTN: AMI AKALLAL-ASAAD PHONE NO : 708 531 9700 2215 ENTERPRISE DRIVE SUITE 1504 SE DECISION MADE: 15-MAR-11 WESTCHESTER IL 60154 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AAXTER A3 POSTERIOR SPINAL SYSTEM AAXTER CO., LTD 510(k) NO: K101374(TRADITIONAL)
ATTN: JACK CHEN PHONE NO : 011 886 289769238 NO. 8-3, SEC. , JHONGSING RD., WUGSE DECISION MADE: 16-MAR-11 TAIPEI TW 24872 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIRAGE MICRO RESMED LTD. 510(k) NO: K110444(SPECIAL)
ATTN: DAVID D'CRUZ PHONE NO : 858 836 5984 9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 16-MAR-11 SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IDS-ISYS IFG-I CONTROL SET IMMUNODIAGNOSTIC SYSTEMS LTD. 510(k) NO: K110412(ABBREVIATED)
ATTN: MICK FENTON PHONE NO : 441 915 190660 10 DIDCOT WAY, BOLDEN BUSINESS PARSE DECISION MADE: 16-MAR-11 BOLDON, TYNE & WEAR UK NE35 9PD510(k) STATEMENT DEVICE: ESCALADE ACETABULAR CUP SYSTEM ORTHO DEVELOPMENT 510(k) NO: K103384(TRADITIONAL)
ATTN: TOM HAUETER PHONE NO : 801 553 9991 12187 S. BUSINESS PARK DR. SE DECISION MADE: 16-MAR-11 DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K103720(TRADITIONAL)
ATTN: KIMERLY A SHARP PHONE NO : 203 602 3665 419 WEST AVE. SE DECISION MADE: 16-MAR-11 STAMFORD CT 06902 6300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOPPLER MONITOR COOK VASCULAR, INC. 510(k) NO: K110347(SPECIAL)
ATTN: JIM FERGUSON PHONE NO : 724 845 8621 1187 MONTGOMERY LANE SE DECISION MADE: 16-MAR-11 VANDERGRIFT PA 15690 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODALIXX AMPRONIX, INC. 510(k) NO: K110108(TRADITIONAL)
ATTN: ASAL NAMINI PHONE NO : 949 273 8000 15 WHATNEY SE DECISION MADE: 16-MAR-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIANCE ENDOSCOPE PROCESSING SYSTEM STERIS CORPORATION 510(k) NO: K110453(SPECIAL)
ATTN: ROBERT SULLIVAN PHONE NO : 440 354 2600 5960 HEISLEY ROAD SE DECISION MADE: 16-MAR-11 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL MEDTEK DEVICES, INC. 510(k) NO: K103375(TRADITIONAL)
ATTN: GREG PEPE PHONE NO : 716 835 7000 595 COMMERCE DR. SE DECISION MADE: 16-MAR-11 AMHERST NY 14228 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NHANES WHOLE BODY DXA REFERENCE DATABASE HOLOGIC, INC. 510(k) NO: K103265(TRADITIONAL)
ATTN: CHRISTINA HURTON PHONE NO : 781 999 7781 35 CROSBY DR. SE DECISION MADE: 16-MAR-11 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY LENSAR, INC. 510(k) NO: K102727(TRADITIONAL)
ATTN: SHIRLEY MCGARVEY PHONE NO : 702 524 3701 2800 DISCOVERY DRIVE SUITE 100 SE DECISION MADE: 16-MAR-11 ORLANDO FL 32826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPLAN RT BRAINLAB, AG 510(k) NO: K103246(TRADITIONAL)
ATTN: ALEXANDER SCHWIERSCH PHONE NO : 498 999 15680 KAPELLENSTRASSE 12 SE DECISION MADE: 16-MAR-11 FELDKIRCHEN GM 85622 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GETINGE 400HC/500HC SERIES STEAM STERILIZER GETINGE SOURCING, LLC 510(k) NO: K103504(TRADITIONAL)
ATTN: BARB SMITH PHONE NO : 585 214 6049 1777 EAST HENRIETTA ROAD SE DECISION MADE: 16-MAR-11 ROCHESTER NY 14623 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZENOFLEX DIMENSION WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K103773(ABBREVIATED)
ATTN: GERHARD POLZER PHONE NO : 490 723 13705219 SCHWENNINGER STRABE 13 SE DECISION MADE: 16-MAR-11 PFORZHEIM GM D-75179 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACKSTOP CATHETER PLUROMED, INC. 510(k) NO: K110491(SPECIAL)
ATTN: JAMES WILKIE PHONE NO : 781 932 0574 25-H OLYMPIA AVENUE SE DECISION MADE: 16-MAR-11 WOBURN MA 01801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IVD-GE02 SPHERE MEDICAL LTD. 510(k) NO: K101947(TRADITIONAL)
ATTN: MARY HUTCHENS PHONE NO : 441 223 875379 HARSTON MILL, HARSTON SE DECISION MADE: 16-MAR-11 CAMBRIDGE UK CM22 7GG 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCELL EVO3 (FORMERLY ACCELL A2I) INTEGRA LIFESCIENCES 510(k) NO: K103742(TRADITIONAL)
ATTN: JENNY FAM PHONE NO : 949 855 7192 2 GOODYEAR SE DECISION MADE: 17-MAR-11 IRVINE CA 92672 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY PANORAMIC CORP. 510(k) NO: K110371(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO CT SE DECISION MADE: 17-MAR-11 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PLANMECA PROMAX 3D MID PLANMECA OY 510(k) NO: K103689(TRADITIONAL)
ATTN: LARS MORING PHONE NO : 358 20 7795500 ASENTAJANKATU 6 SE DECISION MADE: 17-MAR-11 HELSINKI FI FI-00880 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMUS AESTHETIC PLATFORM PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K103664(SPECIAL)
ATTN: SHARON TIMBERLAKE PHONE NO : 781 993 2414 15 NETWORK DRIVE SE DECISION MADE: 17-MAR-11 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO RADICAL Y PULSE CO-OXIMETER MASIMO CORPORATION 510(k) NO: K110028(SPECIAL)
ATTN: SHELLY HARRIS PHONE NO : 949 297 7568 40 PARKER SE DECISION MADE: 17-MAR-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM INFIMED, INC. 510(k) NO: K103416(SPECIAL)
ATTN: JIGAR SHAH PHONE NO : 516 482 9001 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 17-MAR-11 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXFUSION (TM) FIXATION IMPLANT NEXTREMITY SOLUTIONS, LLC 510(k) NO: K110445(TRADITIONAL)
ATTN: ARTHUR A ALFARO PHONE NO : 732 683 9304 167 STONE HILL ROAD SE DECISION MADE: 17-MAR-11 COLTS NECK NJ 07722 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVEREST SPINAL SYSTEM K2M, INC. 510(k) NO: K103440(TRADITIONAL)
ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR.,SE SE DECISION MADE: 17-MAR-11 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONCORDE CURVE SYSTEM JOHNSON & JOHNSON 510(k) NO: K103743(SPECIAL)
ATTN: EUGENE BANG PHONE NO : 508 977 3966 325 PARAMOUNT DR. SE DECISION MADE: 17-MAR-11 RAYNHAM MA 02767 0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WINSTIM JOHARI DIGITAL HEALTHCARE, LTD. 510(k) NO: K102190(SPECIAL)
ATTN: NISHA JOHARI PHONE NO : 912 931 281536 G-582,583, E.P.I.P. BORANADA SE DECISION MADE: 17-MAR-11 JODHPUR ,RAJASTHAN IN 342008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEZO INTERBODY CAGES SYSTEM ULRICH GMBH & CO. KG 510(k) NO: K103814(TRADITIONAL)
ATTN: HANS STOVER PHONE NO : 636 519 0268 612 TRADE CENTER BLVD SE DECISION MADE: 17-MAR-11 CHESTERFIELD MO 63005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT EXAMINATION GLOVES THAI HUA HOLDING CO., LTD. 510(k) NO: K102846(TRADITIONAL)
ATTN: KOK-KEE HON PHONE NO : 703 941 7656 6324 MEETINGHOUSE WAY SE DECISION MADE: 17-MAR-11 ALEXANDRIA VA 22312 1718 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AYCAN WORKSTATION OSIRIX PRO AYCAN DIGITALSYSTEME GMBH 510(k) NO: K103546(SPECIAL)
ATTN: MATTHIAS BROENNER PHONE NO : 499 312 704090 INNERE AUMUEHL STRASSE 5 SE DECISION MADE: 17-MAR-11 WUERZBURG GM 97076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVERE SACRAL PLATES GLOBUS MEDICAL, INC. 510(k) NO: K103072(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610 930 1800 2560 GENERAL ARMISTEAD AVE. VALLEYSE DECISION MADE: 17-MAR-11 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOSIL PROTEIN S ACTIVITY ASSAY INSTRUMENTATION LABORATORY CO. 510(k) NO: K102164(TRADITIONAL)
ATTN: JACQUELINE EMERY PHONE NO : 781 861 4350 180 HARTWELL ROAD SE DECISION MADE: 17-MAR-11 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXSOS (TM) LOCKING PLATE SYSTEM STRYKER CORP. 510(k) NO: K110476(SPECIAL)
ATTN: ESTELA CELI PHONE NO : 201 831 6461 325 CORPORATE DRIVE SE DECISION MADE: 18-MAR-11 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE ASAHI INTECC USA, INC. 510(k) NO: K110553(SPECIAL)
ATTN: YOSHI TERAI PHONE NO : 949 756 8252 2500 RED HILL AVENUE SUITE 210 SE DECISION MADE: 18-MAR-11 SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS BECTON DICKINSON & CO. 510(k) NO: K103798(TRADITIONAL)
ATTN: THALIA CHARLES PHONE NO : 410 316 4145 7 LOVETON CIR. SE DECISION MADE: 18-MAR-11 BALTIMORE MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM SNAP DIAGNOSTICS, L.L.C. 510(k) NO: K110064(SPECIAL)
ATTN: GIL RAVIV PHONE NO : 847 777 0000 5210 CAPITOL DRIVE SE DECISION MADE: 18-MAR-11 WHEELING IL 60090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENTINELLA 102 GENERAL EQUIPMENT FOR MEDICAL IMAG510(k) NO: K110601(TRADITIONAL) ATTN: SEVERINE MOINE PHONE NO : 349 637 22472 CAMINO DE VERA S/N EDIFICIO 9B SE DECISION MADE: 18-MAR-11 VALENCIA SP 46022 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: SYNTHETIC VINYL EXAMINATION GLOVE, POWDER FREE WEIFANG BEIHAI COLOR PRINTING PACK510(k) NO: K110224(TRADITIONAL)
ATTN: HAIQI ZHANG PHONE NO : 865 368 954514 NO 366. YUEHE ROAD WEICHENG DISTRISE DECISION MADE: 18-MAR-11 WEIFANG, SHANDONG CH 261021 510(k) STATEMENT DEVICE: INTRA SKAN DC SKANRAY TECHNOLOGIES 510(k) NO: K103579(TRADITIONAL)
ATTN: PARASURAMAPPA BELUR PHONE NO : 918 212 415559 78 A&B, HOOTAGALLI INDUSTRIAL AREASE DECISION MADE: 18-MAR-11 MYSORE IN 570017 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE MATERIALISE N.V. 510(k) NO: K103136(TRADITIONAL)
ATTN: ALEXANDRA RAZZHIVINA PHONE NO : 321 639 6280 15 TECHNOLOGIELAAN SE DECISION MADE: 18-MAR-11 LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S9 VPAP ADAPT WITH H5I RESMED LTD. 510(k) NO: K102586(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858 836 5984 9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 18-MAR-11 KEARNY MESA CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE MEDTRONIC ABLATION FRONTIERS, LLC 510(k) NO: K102588(TRADITIONAL)
ATTN: BRENDA CLAY PHONE NO : 760 827 0001 2210 FARADAY AVENUE SUIT 100 SE DECISION MADE: 18-MAR-11 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS TERATECH CORP. 510(k) NO: K110482(TRADITIONAL)
ATTN: CHARLES F HOTTINGER PHONE NO : 206 780 7945 P.O. BOX 10074 13221 NE TEEM LOOP SE DECISION MADE: 18-MAR-11 BAINBRIDGE ISLAND WA 98110 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CPR FACE MASK GENUINE FIRST AID LLC 510(k) NO: K102299(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 570 620 0198 150 CHERRY LANE RD. SE DECISION MADE: 18-MAR-11 EAST STROUDSBURG PA 18301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K102779(TRADITIONAL)
ATTN: JANET M FOSE PHONE NO : 302 631 8826 P.O. BOX 6101 MAILBOX 514 SE DECISION MADE: 18-MAR-11 NEWARK DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOULE MULTI-PLATFORM SYSTEM SCITON, INC. 510(k) NO: K101916(TRADITIONAL)
ATTN: JAY M PATEL PHONE NO : 650 493 9155 925 COMMERCIAL ST. SE DECISION MADE: 18-MAR-11 PALO ALTO CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOW PROFILE SCREWS ARTHREX, INC. 510(k) NO: K103705(TRADITIONAL)
ATTN: COURTNEY SMITH PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 18-MAR-11 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706 LINDE GAS NORTH AMERICA LLC 510(k) NO: K101792(TRADITIONAL)
ATTN: MICHAEL PIACENZA PHONE NO : 908 508 2729 575 MOUNTAIN AVE SE DECISION MADE: 18-MAR-11 MURRAY HILL NJ 07974 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS AVALON FETAL MONITOR PHILIPS MEDIZIN SYSTEME BOBLINGEN 510(k) NO: K102958(TRADITIONAL)
ATTN: MICHAEL ASMALSKY PHONE NO : 497 031 4631277 HEWLETT-PACKARD-STR. 2 SE DECISION MADE: 18-MAR-11 BOBLINGEN GM 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS DANMEDICAL LIMITED 510(k) NO: K100424(TRADITIONAL) ATTN: IAN DRYSDALE PHONE NO : 441 463 667316 THE GREENHOUSE, BEECHWOOD BUSINESSSE DECISION MADE: 21-MAR-11 INVERNESS HIGHLANDS UK 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEM-4030 OMRON HEALTHCARE, INC. 510(k) NO: K110501(SPECIAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 21-MAR-11 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 SERIES GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K110299(TRADITIONAL)
ATTN: PATRICK CHOW PHONE NO : 008 522 8516789 ZHU KENG INDUSTRIAL ZONE PING SHANSE DECISION MADE: 21-MAR-11 SHENSHEN, GUANG DONG CH 518118 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MPACT ACETABULAR SYSTEM MEDACTA INTERNATIONAL 510(k) NO: K103721(TRADITIONAL)
ATTN: NATALIE J KENNEL PHONE NO : 858 705 0350 13721 VIA TRES VISTA SE DECISION MADE: 21-MAR-11 SAN DIEGO CA 92129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JTS EXTENDEABLE IMPLANT STANMORE IMPLANTS WORLDWIDE LTD. 510(k) NO: K092138(TRADITIONAL)
ATTN: GERARD J PRUD'HOMME PHONE NO : 202 637 5713 555 THIRTEENTH ST, NW SE DECISION MADE: 22-MAR-11 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES SYNVASIVE TECHNOLOGY, INC. 510(k) NO: K093046(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8726 FERRARA CT SE DECISION MADE: 22-MAR-11 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER ACCESS SCIENTIFIC, INC. 510(k) NO: K101422(TRADITIONAL)
ATTN: ALBERT MISAJON PHONE NO : 858 259 8333 12526 HIGH BLUFF DRIVE SUITE 360 SE DECISION MADE: 22-MAR-11 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T PHILIPS HEALTHCARE 510(k) NO: K110151(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425 487 7312 22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 22-MAR-11 BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOPRO 281 SOPRO 510(k) NO: K103813(TRADITIONAL)
ATTN: RICK ROSATI PHONE NO : 800 289 6367 124 GAITHER DRIVE SUITE 140 SE DECISION MADE: 22-MAR-11 MT. LAUREL NJ 08054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFEPAK 15 MONITOR/DEFIBRILLATOR PHYSIO-CONTROL, INC. 510(k) NO: K103567(TRADITIONAL)
ATTN: MICHELLE ACKERMANN PHONE NO : 425 867 4744 11811 WILLOWS RD., N.E. SE DECISION MADE: 22-MAR-11 REDMOND WA 98052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIDMARK IQECG BRENTWOOD MEDICAL TECHNOLOGY CORP.510(k) NO: K103640(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949 262 0411 3722 AVE. SAUSALITO SE DECISION MADE: 22-MAR-11 IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MUSTANG BALLOON DILATATION CATHETERS BOSTON SCIENTIFIC 510(k) NO: K103751(TRADITIONAL)
ATTN: ANNE V ROSSI PHONE NO : 763 255 0681 ONE SCIMED PLACE SE DECISION MADE: 22-MAR-11 MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOPHOS XG 3D / CEPH SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K103711(TRADITIONAL)
ATTN: FRITZ KOLLE PHONE NO : 496 251 160 FABRIKSTRASSE 31 SE DECISION MADE: 22-MAR-11 BENSHEIM GM 64625 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IDEAL IQ SOFTWARE OPTION GE MEDICAL SYSTEMS 510(k) NO: K103411(TRADITIONAL)
ATTN: TRACEY FOX PHONE NO : 262 521 6079 3200 N GRANDVIEW BLVD W-827 SE DECISION MADE: 22-MAR-11 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONFIDENT SURGERY SUITE 300, MODEL CSS300 SURGICEYE GMBH 510(k) NO: K101887(TRADITIONAL)
ATTN: MORITZ HOYER PHONE NO : 498 954 043046 FRIEDENSTRASSE 18A SE DECISION MADE: 22-MAR-11 MUNICH, BAVARIA GM 81671 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES ERBE USA, INC. 510(k) NO: K103696(TRADITIONAL)
ATTN: JOHN TARTAL PHONE NO : 770 955 4400 2225 NORTHWEST PKWY. SE DECISION MADE: 22-MAR-11 MARIETTA GA 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APOLONIA LASER IMPLANT SYSTEM CSM IMPLANT CO., LTD 510(k) NO: K102635(TRADITIONAL)
ATTN: JOYCE BANG PHONE NO : 562 404 8466 325 N. PUENTE ST. UNIT B SE DECISION MADE: 22-MAR-11 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROTATING GAMMA SYSTEM INFINI (INFINI) MASEP MEDICAL SCIENCE & TECH.DEVEL510(k) NO: K102533(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 706 7456 55 NORTHREN BLVD SUITE 200 SE DECISION MADE: 22-MAR-11 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT IRIS INTERNATIONAL INC., A DIVISIO510(k) NO: K101852(TRADITIONAL)
ATTN: DAVID W GATES PHONE NO : 818 527 7264 9172 ETON AVENUE SE DECISION MADE: 23-MAR-11 CHATSWORTH CA 91311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTA FLASH H-TTG IGG INOVA DIAGNOSTICS, INC. 510(k) NO: K101644(TRADITIONAL)
ATTN: RUFUS BURLINGAME PHONE NO : 858 586 9900 9900 OLD GROVE RD. SE DECISION MADE: 23-MAR-11 SAN DIEGO CA 92131 1638 510(k) STATEMENT DEVICE: CELSTAT BAXTER HEALTHCARE CORP. 510(k) NO: K103245(TRADITIONAL)
ATTN: SAMUEL MATHEW PHONE NO : 847 948 3587 1620 WAUKEGAN ROAD SE DECISION MADE: 23-MAR-11 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K110552(SPECIAL)
ATTN: RYAN BORMANN PHONE NO : 901 867 4409 5677 AIRLINE RD. SE DECISION MADE: 23-MAR-11 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE RUBBERCARE PROTECTION PRODUCTS (M)510(k) NO: K103661(TRADITIONAL)
ATTN: LIM KWEE SHYAN PHONE NO : 606 677 2781 OFF JALAN SENAWANG EMPAT SENAWANG SE DECISION MADE: 23-MAR-11 SEREMBAN, NEGERI SEMBILAN MY 70510(k) STATEMENT DEVICE: FORZA SPACER SYSTEM ORTHOFIX INC. 510(k) NO: K103111(TRADITIONAL)
ATTN: DARLA CHEW PHONE NO : 214 937 2000 3451 PLANO PARKWAY SE DECISION MADE: 23-MAR-11 LEWISVILLE TX 75056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LANX LATERAL LANX, INC. 510(k) NO: K103666(TRADITIONAL)
ATTN: ALAN BRUKHOLDER PHONE NO : 303 443 7500 390 INTERLOCKEN CRESCENT SUITE 890SE DECISION MADE: 23-MAR-11 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMMETRY SACROILIAC JOINT FUSION SYSTEM ZYGA TECHNOLOGY, INC. 510(k) NO: K110512(SPECIAL)
ATTN: DIANE BRINZA PHONE NO : 612 455 1061 700 10TH AVENUE SOUTH, SUITE 400 SE DECISION MADE: 23-MAR-11 MINNEAPOLIS MN 55415 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIONEER SPINAL PROCESS FUSION PLATE PIONEER SURGICAL TECHNOLOGY, INC 510(k) NO: K110367(SPECIAL)
ATTN: EMILY M DOWNS PHONE NO : 906 225 5602 375 RIVER PARK CIRCLE SE DECISION MADE: 23-MAR-11 Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTRALEX ST HERNIA PATCH C.R. BARD, INC. 510(k) NO: K101928(TRADITIONAL)
ATTN: MICHELLE GODIN PHONE NO : 401 825 8589 100 CROSSINGS BOULEVARD SE DECISION MADE: 23-MAR-11 WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTRIO ST HERNIA PATCH C.R. BARD, INC. 510(k) NO: K101920(TRADITIONAL)
ATTN: MICHELLE GODIN PHONE NO : 401 825 8589 100 CROSSINGS BOULEVARD SE DECISION MADE: 23-MAR-11 WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM OON CORP. RESOURCES 510(k) NO: K103650(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775 342 2612 198 AVE DE LA DEMERALD SE DECISION MADE: 23-MAR-11 SPARKS NV 89434 9550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT ANTHOGYR SAS 510(k) NO: K102241(TRADITIONAL)
ATTN: BRAYETTE SABINE PHONE NO : 330 450 580237 2237, AVENUE ANDRE LASQUIN SE DECISION MADE: 23-MAR-11 SALLANCHES FR 74700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM STELKAST COMPANY 510(k) NO: K094035(TRADITIONAL)
ATTN: DONALD A STEVENS PHONE NO : 724 941 6368 200 HIDDEN VALLEY RD. SE DECISION MADE: 24-MAR-11 MCMURRAY PA 15317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA REGULATORY AND MARKETING SERVICES,510(k) NO: K101721(SPECIAL)
ATTN: ARTHUR WARD PHONE NO : 813 645 2855 962 ALLEGRO LANE SE DECISION MADE: 24-MAR-11 APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE ZIMMER CAS 510(k) NO: K110054(SPECIAL)
ATTN: CHRISTOPHER MCLEAN PHONE NO : 514 861 4074 75 QUEEN STREET SUITE 3300 SE DECISION MADE: 24-MAR-11 MONTREAL, QUEBEC CA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCOMXL ACTIVE ARTICULATION BIOMET MANUFACTURING CORP. 510(k) NO: K110555(SPECIAL)
ATTN: BEKCY EARL PHONE NO : 574 267 6639 PO BOX 587 SE DECISION MADE: 24-MAR-11 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMO SCIENTIFIC MAS R DOA TOTAL MICROGENICS CORPORATION 510(k) NO: K103656(TRADITIONAL)
ATTN: LISA CHARTER PHONE NO : 510 979 5142 46360 FREMONT BLVD. SE DECISION MADE: 24-MAR-11 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOBILEECG SYSTEM MEMTEC CORP. 510(k) NO: K103427(TRADITIONAL)
ATTN: DENNIS GARBOSKI PHONE NO : 603 893 8080 68 STILES RD. UNIT D SE DECISION MADE: 24-MAR-11 SALEM NH 03079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABL835 FLEX ANALYZER WITH PLEURAL PH RADIOMETER MEDICAL APS 510(k) NO: K110416(TRADITIONAL)
ATTN: SOREN BOGESTRAND PHONE NO : 453 827 3852 AAKANDEVEJ 21 SE DECISION MADE: 24-MAR-11 BROENSHOEJY DA DK-2700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BALANCED KNEE SYSTEM REVISION OFFSET TIBIA ORTHO DEVELOPMENT 510(k) NO: K103837(TRADITIONAL)
ATTN: TOM HAUETER PHONE NO : 801 553 9991 12187 S. BUSINESS PARK DR. SE DECISION MADE: 24-MAR-11 DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARCANVAS RIS / PACS CLEARCANVAS INC. 510(k) NO: K110332(TRADITIONAL)
ATTN: CLINTON CHAU PHONE NO : 647 547 8006 439 UNIVERSITY AVE. SUITE 1920 SE DECISION MADE: 24-MAR-11 TORONTO, ON CA M5G 1Y8 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ZEST PETITE NASAL MASK FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K103786(TRADITIONAL)
ATTN: TINA MASON PHONE NO : 006 495 740100 15 MAURICE PAYKEL PLACE SE DECISION MADE: 24-MAR-11 EAST TAMAKI, AUCKLAND NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... ELITECHGROUP VITAL SCIENTIFIC BV 510(k) NO: K102647(TRADITIONAL)
ATTN: DEBRA K HUTSON PHONE NO : 425 482 5174 21720 23RD DR SE SUITE 150 SE DECISION MADE: 24-MAR-11 BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERFORMAX TOTAL FACE MASK RESPIRONICS, INC. 510(k) NO: K103395(SPECIAL)
ATTN: MICHELLE BRINKER PHONE NO : 724 387 4146 365 PLUM INDUSTRIAL COURT SE DECISION MADE: 24-MAR-11 PITTSBURGH PA 15239 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANUKATEX MANUKA MEDICAL LIMITED 510(k) NO: K110042(TRADITIONAL)
ATTN: JAMES SMITH PHONE NO : 949 340 7261 29442 POINTE ROYALE SE DECISION MADE: 24-MAR-11 LAGUNA NIGUEL CA 92677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BODYTOM NL 4000 NEUROLOGICA CORPORATION 510(k) NO: K102677(TRADITIONAL)
ATTN: DONALD D FICKETT PHONE NO : 978 564 8523 14 ELECTRONICS AVENUE SE DECISION MADE: 24-MAR-11 DANVERS MA 01923 1011 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GMK REVISION KNEE SC LINERS MEDACTA INTERNATIONAL, SA 510(k) NO: K103170(SPECIAL)
ATTN: NATALIE J KENNEL PHONE NO : 858 705 0350 13721 VIA TRES VISTA SE DECISION MADE: 24-MAR-11 SAN DIEGO CA 92129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIPAP AVAPS VENTILATORY SUPPORT SYSTEM RESPIRONICS, INC. 510(k) NO: K102465(TRADITIONAL)
ATTN: ELAINE LARKIN PHONE NO : 724 387 5350 1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 24-MAR-11 MONROEVILLE PA 15146 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLINE RETRACTABLE SAFETY SYRINGE MEDLINE INDUSTRIES, INC. 510(k) NO: K101560(ABBREVIATED)
ATTN: MATT CLAUSEN PHONE NO : 847 643 4785 ONE MEDLINE PLACE SE DECISION MADE: 25-MAR-11 MUNDELEIN IL 60060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS VERTEX-DENTAL B.V. 510(k) NO: K102640(TRADITIONAL)
ATTN: WILLIAM F GREENROSE PHONE NO : 220 RIVER ROAD SE DECISION MADE: 25-MAR-11 CLAREMONT NH 03743 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHODONTIC SCREW OSSTEM IMPLANT CO.,LTD 510(k) NO: K103105(SPECIAL)
ATTN: PATRICK LIM PHONE NO : 267 759 7030 85 BEN FAIRLESS DR. SE DECISION MADE: 25-MAR-11 FAIRLESS HILLS PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER ETHICON ENDO-SURGERY, INC. 510(k) NO: K110385(TRADITIONAL)
ATTN: ASIFA VONHOF PHONE NO : 513 337 3118 4545 CREEK RD. SE DECISION MADE: 25-MAR-11 CINCINNATI OH 45242 2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LANX SPINAL SYSTEM LANX, INC. 510(k) NO: K103237(SPECIAL)
ATTN: DAMON BELLONI PHONE NO : 303 443 7500 390 INTERLOCKEN CRESCENT SUITE 890SE DECISION MADE: 25-MAR-11 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTEC OS SPINAL FIXATION SYSTEM SYNTEC SCIENTIFIC CORP. 510(k) NO: K101971(TRADITIONAL)
ATTN: CAROL CHANG PHONE NO : 886 479 87099 2, KUNG SAN ROAD, CHUAN SHING INDUSE DECISION MADE: 25-MAR-11 CHANG HUA TW 509 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGAMAX 5 ETHICON ENDO-SUGERY, LLC 510(k) NO: K110699(TRADITIONAL)
ATTN: EMILY KRUETZKAMP PHONE NO : 513 337 1546 4545 CREEK RD. SE DECISION MADE: 25-MAR-11 CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE ZOLL MEDICAL CORPORATION 510(k) NO: K110526(SPECIAL)
ATTN: EILEEN M BOYLE PHONE NO : 978 421 9171 269 MILL ROAD SE DECISION MADE: 25-MAR-11 CHELMSFORD MA 01824 4105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX PS KNEE SYSTEM OMNI LIFE SCIENCE, INC. 510(k) NO: K102578(TRADITIONAL)
ATTN: RADHIKA PONDICHERRY PHONE NO : 774 226 1852 50 O'CONNELL WAY SE DECISION MADE: 25-MAR-11 EAST TAUNTON MA 02718 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPTIVA SPINE FUSELOX CERVICAL CAGE CAPTIVA SPINE, INC 510(k) NO: K110585(SPECIAL)
ATTN: JOHN SANDERS PHONE NO : 954 993 5581 2361 NW 105TH LANE SE DECISION MADE: 25-MAR-11 SUNRISE FL 33322 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240 THERMEDX, LLC 510(k) NO: K102275(TRADITIONAL)
ATTN: JOHN R SCOVILLE PHONE NO : 440 542 0883 31200 SOLON ROAD UNIT 1 SE DECISION MADE: 25-MAR-11 SOLON OH 44139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUCLEAR INCISOR PLUS BLADE 2.9 SMITH & NEPHEW, INC. 510(k) NO: K103389(TRADITIONAL)
ATTN: JANICE HASELTON PHONE NO : 978 749 1494 150 MINUTEMAN RD. SE DECISION MADE: 25-MAR-11 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH CO., LTD. 510(k) NO: K102196(TRADITIONAL)
ATTN: DAVE KIM PHONE NO : 832 623 2099 333 MEADOWLANDS PARKWAY #303 SE DECISION MADE: 25-MAR-11 SECAUCUS NJ 07094 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS, BAXTER HEALTHCARE CORP. 510(k) NO: K103551(TRADITIONAL)
ATTN: NANETTE HEDDEN PHONE NO : 847 270 4871 1620 WAUKEGAN ROAD SE DECISION MADE: 25-MAR-11 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIT TEST C&B VOCO GMBH 510(k) NO: K110050(TRADITIONAL)
ATTN: MANFRED T PLAUMANN PHONE NO : 494 721 7190 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 28-MAR-11 CUXHAVEN GM D-27472 510(k) STATEMENT DEVICE: CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L AIRSEP CORP. 510(k) NO: K101154(TRADITIONAL)
ATTN: PETER WEISENBORN PHONE NO : 716 691 0202 401 CREEKSIDE DR. SE DECISION MADE: 28-MAR-11 BUFFALO NY 14228 2085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PANTINO PRO POSITINER SOMNOMED INC. 510(k) NO: K102521(TRADITIONAL)
ATTN: BRADLEY SOUTHWORTH PHONE NO : 940 381 5200 3537 TEASLEY LANE SE DECISION MADE: 28-MAR-11 DENTON TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUTRAC BOSTON SCIENTIFIC CORP. 510(k) NO: K110686(SPECIAL)
ATTN: LAUREN ANDERSON PHONE NO : 508 683 4707 100 BOSTON SCIENTIFIC WAY M21 SE DECISION MADE: 28-MAR-11 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6 SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K093987(TRADITIONAL)
ATTN: DONNA VELASQUEZ PHONE NO : 310 645 8200 5210 PACIFIC CONCOURSE DRIVE SE DECISION MADE: 28-MAR-11 LOS ANGELES CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FX 222-02 POWERED WHEELCHAIR LANZHOU WANLI AVIATION ELECTROMECH510(k) NO: K110036(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 422 465396 16F-2(16A),NO.462,SEC.2, CHONGDE RSE DECISION MADE: 28-MAR-11 TAICHUNG, TAIWAN TW 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEW STETIC ACRYLICS NEW STETIC 510(k) NO: K102874(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813 645 2855 962 ALLEGRO LANE SE DECISION MADE: 28-MAR-11 APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D COOK IRELAND LTD 510(k) NO: K101530(TRADITIONAL)
ATTN: JACINTA KILMARTIN PHONE NO : 353 613 34440 O'HALLORAN ROAD NATIONAL TECHNOLOGSE DECISION MADE: 29-MAR-11 LIMERICK EI EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL RADIOGRAPHY CANON, INC.-MEDICAL EQUIPMENT GROU510(k) NO: K103591(SPECIAL)
ATTN: KOJI KUBO PHONE NO : 814 254 81253 3F 2-17-6 AKEBONO-CHO SE DECISION MADE: 29-MAR-11 TACHIKAWA-SHI, TOKYO JA 190-001510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUET DRF CMT MEDICAL TECHNOLOGIES, LTD. 510(k) NO: K103038(ABBREVIATED)
ATTN: SHLOMI DINES PHONE NO : 009 724 8566220 HACARMEL ST BUILDING 7/2 P.O.B. 11SE DECISION MADE: 29-MAR-11 YOQNEAM ILIT IS 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXIVA TRACTIP BOSTON SCIENTIFIC CORP. 510(k) NO: K110685(SPECIAL)
ATTN: LAUREN ANDERSON PHONE NO : 508 683 4707 100 BOSTON SCIENTIFIC WAY M21 SE DECISION MADE: 29-MAR-11 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BILI-THERAPY SPOT TYPE ATOM MEDICAL CORPORATION 510(k) NO: K103828(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 29-MAR-11 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL MR INSTRUMENTS, INC. 510(k) NO: K110591(TRADITIONAL)
ATTN: JOSHUA J HOLWELL PHONE NO : 952 746 1435 5610 ROWLAND ROAD SUITE 145 SE DECISION MADE: 29-MAR-11 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K103596(SPECIAL)
ATTN: KATHERINE Y CHOI PHONE NO : 203 602 3568 419 WEST AVE. SE DECISION MADE: 29-MAR-11 STAMFORD CT 06902 6300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTRO SENSOR -BODY COMPOSITION L.D. TECHNOLOGY, LLC 510(k) NO: K103026(TRADITIONAL)
ATTN: RICHARD CLEMENT PHONE NO : 305 594 2145 11459 NW 34 STREET SE DECISION MADE: 29-MAR-11 MIAMI FL 33178 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM GENORAY AMERICA INC. 510(k) NO: K103425(TRADITIONAL)
ATTN: JAE KIM PHONE NO : 714 289 8020 1073 N. Batavia St SE DECISION MADE: 29-MAR-11 Orange CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOPAP SYSTEM CHILDRENS MEDICAL VENTURES LLC 510(k) NO: K103410(TRADITIONAL)
ATTN: SCOTT WRIGHT PHONE NO : 412 380 8812 SUITE 200, 3919 WILLIAM PENN HIGHWSE DECISION MADE: 30-MAR-11 MURRYSVILLE PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUCLEAR MORCELLATOR SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K110038(SPECIAL)
ATTN: JANICE HASELTON PHONE NO : 978 749 1494 150 MINUTEMAN ROAD SE DECISION MADE: 30-MAR-11 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHLORASHIELDTM ANTIMICROBIAL DRESSING CARE FUSION 213 LLC 510(k) NO: K103106(TRADITIONAL)
ATTN: ARLEN JOHNSON PHONE NO : 800 523 0502 11400 TOMAHAWK CREEK PARKWAY SUITESE DECISION MADE: 30-MAR-11 LEAWOOD KS 66211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM ALPHATEC SPINE, INC. 510(k) NO: K102402(TRADITIONAL) ATTN: MARY STANNERS PHONE NO : 760 494 6771 5818 EL CAMINO REAL SE DECISION MADE: 30-MAR-11 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R BAXTER HEALTHCARE CORP. 510(k) NO: K102936(TRADITIONAL)
ATTN: DAVID E CURTIN PHONE NO : 847 473 6079 1620 WAUKEGAN RD. SE DECISION MADE: 30-MAR-11 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAUNYING INFRARED LAMP FOSHAN GAUNYING ELECTRONICS CO., L510(k) NO: K110721(TRADITIONAL)
ATTN: LADI LEE PHONE NO : 86 755 83107610 HI-TECH INDUSTRIAL DEVELOPMENT SE DECISION MADE: 30-MAR-11 FOSHAN, GUANGDONG CH 52800 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ODFS PACE ODSTOCK MEDICAL LTD 510(k) NO: K102115(TRADITIONAL)
ATTN: STEVEN CROOK PHONE NO : 44 172 2439541 SALISBURY DISTRICT HOSPITAL SE DECISION MADE: 30-MAR-11 SALISBURY, WILTSHIRE UK SP2 8BJ510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IOS FASTSCAN SPRAY IOS TECHNNOLOGIES, INC. 510(k) NO: K103586(TRADITIONAL)
ATTN: DUANE DURBIN PHONE NO : 858 202 3363 3978 SORRENTO VALLEY BLVD. SUITE 2SE DECISION MADE: 30-MAR-11 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EM-9000 ELITE MEDICAL INC 510(k) NO: K101482(TRADITIONAL)
ATTN: STEVEN J DE BROCK PHONE NO : 770 552 0626 4343 SHALLOWFORD ROAD SUITE H-4B MSE DECISION MADE: 31-MAR-11 ATLANTA GA 30062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR) INNOVATIVE GLOVES CO; LTD 510(k) NO: K103670(TRADITIONAL)
ATTN: RAJEEV SOOD PHONE NO : 667 450 2251 800 MOO 4,SAAMBIN-BAN KLANG RD KUASE DECISION MADE: 31-MAR-11 HATYAI, SONGKHLA TH 90110 510(k) STATEMENT DEVICE: SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE BIOMERS PRODUCTS, LLC 510(k) NO: K110796(TRADITIONAL)
ATTN: DARYL WISDAHL PHONE NO : 604 909 1265 1275 WEST 6TH AVENUE SUITE 399 SE DECISION MADE: 31-MAR-11 VANCOUVER, BC CA V6H 1A6 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BPA-FREE PIT AND FISSURE SEALANT NOVOCOL INC. DBA SEPTODONT AND CON510(k) NO: K110058(ABBREVIATED)
ATTN: CORA BRACHO-TROCONIS PHONE NO : 303 665 7535 416 S. TAYLOR AVE SE DECISION MADE: 31-MAR-11 LOUISVILLE CO 80027 510(k) STATEMENT DEVICE: INTELLIVUE PATIENT MONITOR PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K110622(SPECIAL)
ATTN: HERBERT VAN DYK PHONE NO : 497 031 4631734 HEWLETT-PACKARD STR.2 SE DECISION MADE: 31-MAR-11 BOEBLINGEN GM D 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX BIOCOMPOSITE SUTURETAK ARTHREX, INC. 510(k) NO: K110660(SPECIAL)
ATTN: COURTNEY SMITH PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 31-MAR-11 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TDS ABUTMENT FOR FRIADENT XIVE POU YU BIOTECHNOLOGY CO., LTD. 510(k) NO: K103339(TRADITIONAL)
ATTN: DANIEL TSAO PHONE NO : 886 047 685660 NO. 6, FUGONG RD. SE DECISION MADE: 31-MAR-11 FUSING TOWNSHIP, CHANGHUA CTY T510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A SCOPE ACTIVE SIGNAL TECHNOLOGIES, INC. 510(k) NO: K103499(TRADITIONAL)
ATTN: HARVEY KNAUSS PHONE NO : 832 675 9281 11874 SOUTH EVELYN CIR. SE DECISION MADE: 31-MAR-11 HOUSTON TX 77071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSPIRA AIR BALLOON DILATION SYSTEM ACCLARENT, INC. 510(k) NO: K110218(SPECIAL)
ATTN: KERI YEN PHONE NO : 650 687 5874 1525-B O'BRIEN DR. SE DECISION MADE: 31-MAR-11 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAKONG ULTRASONIC SCALER LAKONG MEDICAL DEVICE COMPANY, LTD510(k) NO: K103498(TRADITIONAL)
ATTN: DANNY WANG PHONE NO : 626 810 4337 18525 E. GALE AVE. SE DECISION MADE: 31-MAR-11 CITY OF INDUSTRY CA 91748 510(k) STATEMENT DEVICE: ZMACHINE, MODEL DT-100 CONSOLIDATED RESEARCH OF RICHMOND,510(k) NO: K101830(TRADITIONAL)
ATTN: RICHARD KAPLAN PHONE NO : 216 289 2331 26250 EUCLID AVE SUITE 024 SE DECISION MADE: 31-MAR-11 EUCLID OH 44132 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 262 TOTAL WITH SUMMARIES 244 TOTAL WITH STATEMENTS 18