Medical Devices
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December 2010 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD December 2010 DEVICE: V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40 VALERITAS, LLC 510(k) NO: K100504(TRADITIONAL) ATTN: SCOTT HUIE PHONE NO : 508 845 8744 800 BOSTON TURNPIKE SE DECISION MADE: 01-DEC-10 SHREWSBURY MA 01545 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CCPOINT EURO-DIAGNOSTICA AB 510(k) NO: K093908(TRADITIONAL) ATTN: ROBERT SCHIFF PHONE NO : 973 227 1830 1129 BLOOMFIELD AVENUE SE DECISION MADE: 01-DEC-10 WEST CALDWELL NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET OVESCO ENDOSCOPY AG 510(k) NO: K101428(TRADITIONAL) ATTN: ARNE BRIEST PHONE NO : 497 214 764847 KASTELLSTR. 8 BADEN WUERTTEMBERG SE DECISION MADE: 01-DEC-10 KARLSRUHE GM 76227 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 LIFELINE SYSTEMS, INC. 510(k) NO: K103214(SPECIAL) ATTN: CARLOS O ACOSTA PHONE NO : 508 988 1366 111 LAWRENCE ST. SE DECISION MADE: 01-DEC-10 FRAMINGHAM MA 01702 8156 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SL3 DISCUS DENTAL, LLC 510(k) NO: K102639(SPECIAL) ATTN: CLARK D VONAHSEN PHONE NO : 310 845 8216 8550 HIGUERA ST. SE DECISION MADE: 01-DEC-10 CULVER CITY CA 90232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LLX240AB01 SAMSUNG MOBILE DISPLAY CO., LTD 510(k) NO: K102587(TRADITIONAL) ATTN: DAVE KIM PHONE NO : 832 623 2099 333 MEADOWLANDS PKWY #303 SE DECISION MADE: 01-DEC-10 SECAUCUS NJ 07094 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEPARIN ASSAY CONTROLS MEDTRONIC INC. 510(k) NO: K103313(SPECIAL) ATTN: JEFFREY L KOLL PHONE NO : 763 514 9842 8200 CORAL SEA STREET NE SE DECISION MADE: 01-DEC-10 MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOMOPHASE OCTIS TOMOPHASE CORPORATION 510(k) NO: K102599(TRADITIONAL) ATTN: DEREK BEAUPRE PHONE NO : 603 264 3831 14 BURGUNDY DRIVE SE DECISION MADE: 01-DEC-10 HAMPTON NH 03842 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM NUVASIVE, INC. 510(k) NO: K102514(SPECIAL) ATTN: ELISA KETCHUM PHONE NO : 858 320 4588 7475 LUSK BLVD SE DECISION MADE: 01-DEC-10 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITALA CONTINENCE CONTROL DEVICE CONVATEC INC 510(k) NO: K102536(TRADITIONAL) ATTN: CHARLES RYAN PHONE NO : 908 904 2500 200 HEADQUARTERS PARK DRIVE SE DECISION MADE: 01-DEC-10 SKILLMAN NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRAVO PH MONITORING SYSTEM AND ACCESSORIES GIVEN IMAGING LTD. 510(k) NO: K102543(TRADITIONAL) ATTN: TIM THOMAS PHONE NO : 972 490 97936 P.O. BOX 258 NEW INDUSTRIAL PARK SE DECISION MADE: 01-DEC-10 YOQNEAM IS 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONCORDE CURVE SYSTEM DEPUY SPINE 510(k) NO: K101923(SPECIAL) ATTN: EUGENE BANG PHONE NO : 508 977 3966 325 PARAMOUNT DR. SE DECISION MADE: 01-DEC-10 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLEEK OTW PTA CATHETERS CLEAR STREAM TECHNOLOGIES, LTD. 510(k) NO: K102035(SPECIAL) ATTN: FIONA NI MHULLAIN PHONE NO : 353 53 92371111 MOYNE UPPER, ENNISCORTHY SE DECISION MADE: 01-DEC-10 COUNTY WEXFORD EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SECRMARK BIOPSY SITE MARKING SYSTEM HOLOGIC, INC. 510(k) NO: K102768(SPECIAL) ATTN: ALYSSA M LOBO PHONE NO : 877 887 2767 6100 TECHNOLOGY CENTER DRIVE SE DECISION MADE: 02-DEC-10 INDIANAPOLIS IN 46278 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K101577(SPECIAL) ATTN: DIANA HONG PHONE NO : 862 164 264467 SUITE 5D, NO. 19, LANE 999 ZHONGSHSE DECISION MADE: 02-DEC-10 SHANGHAI CH 20030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENOVO (TM) SUTURE ANCHORS, RENOVO SS & PEEK PRODUCT CODES, MODELS 100-2001 THRU 100-520X, 400-0002 THRU 4007026X CORE ESSENCE ORTHOPAEDICS, INC. 510(k) NO: K101126(TRADITIONAL) ATTN: JEFF MILLER PHONE NO : 215 310 9534 575A VIRGINIA DRIVE SE DECISION MADE: 02-DEC-10 FT WASHINGTON PA 19034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADHESIVE ELECTRODES RENO MEDICAL LIMITED 510(k) NO: K102842(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 164 264467 P.O. BOX 237-023 SE DECISION MADE: 02-DEC-10 SHANGHAI CH 200237 510(k) STATEMENT DEVICE: HYPERQ AD-100 SYSTEM BIOLOGICAL SIGNAL PROCESSING LTD. 510(k) NO: K102579(SPECIAL) ATTN: GEORGE J HATTUB PHONE NO : 508 479 6116 291 HILLSIDE AVENUE SE DECISION MADE: 02-DEC-10 SOMERSET MA 02726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAMINOPLASY PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K103284(SPECIAL) ATTN: LISA M BOYLE PHONE NO : 610 984 9274 3773 CORPORATE PWKY. SE DECISION MADE: 02-DEC-10 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) BREATHE TECHNOLOGIES, INC. 510(k) NO: K102525(TRADITIONAL) ATTN: CRAIG COOMBS PHONE NO : 510 337 0140 1193 SHERMAN ST. SE DECISION MADE: 02-DEC-10 ALAMEDA CA 94501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) VENTUS MEDICAL, INC. 510(k) NO: K102404(TRADITIONAL) ATTN: MICHAEL NEVARES PHONE NO : 650 632 4189 1301 SHOREWAY ROAD SUITE 425 SE DECISION MADE: 02-DEC-10 BELMONT CA 94002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONSENSUS TAPERSET HIP SYSTEM CONSENSUS ORTHOPEDICS, INC 510(k) NO: K102399(TRADITIONAL) ATTN: MATTHEW HULL PHONE NO : 916 355 7156 1115 WINFIELD WAY SUITE 100 SE DECISION MADE: 02-DEC-10 EL DORADO HILLS CA 95762 9623 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVOLVE EPS ORTHOLOC WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K102352(SPECIAL) ATTN: KELSEY LEE PHONE NO : 901 290 5909 5677 AIRLINE RD. SE DECISION MADE: 02-DEC-10 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTROCARDIOGRAPH EDAN INSTRUMENTS, INC. 510(k) NO: K102830(SPECIAL) ATTN: YUE QIUHONG (TRACY) PHONE NO : 86 755 26899197 3/F-B NANSHAN MEDICAL EQUIPMEN PARSE DECISION MADE: 02-DEC-10 SHENZHEN CH 518067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENVIEW (TM) CAREFUSION 2200 510(k) NO: K102179(TRADITIONAL) ATTN: PATRICIA A AYERS PHONE NO : 858 246 0439 6215 FERRIS SQUARE, SUITE #100 SE DECISION MADE: 02-DEC-10 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS GRIFFITHS AND NIELSEN LTD 510(k) NO: K101224(TRADITIONAL) ATTN: EDWIN LINDSAY PHONE NO : 447 917 134922 STANE STREET, SLINFORD SE DECISION MADE: 03-DEC-10 HORSHAM, WEST SUSSEX UK RH13 0T510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOHARNESS ZEPHYR TECHNOLOGY CORPORATION 510(k) NO: K100040(TRADITIONAL) ATTN: CODE CUBITT PHONE NO : 443 569 3603 1 ANNAPOLIS STREET, SUITE 200 SE DECISION MADE: 03-DEC-10 ANNAPOLIS MD 21401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PACENTRIC CONNECT, TRAVELER AND WEB FIMREITE SOFTWARE AS 510(k) NO: K100837(ABBREVIATED) ATTN: SVEIN FIMREITE PHONE NO : 47 99 744114 TORGGATA 26 SE DECISION MADE: 03-DEC-10 HORTEN NO 3181 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANYPLUS PEEK CAGES GS MEDICAL CO., LTD. 510(k) NO: K100516(TRADITIONAL) ATTN: DONALD W GUTHNER PHONE NO : 603 369 3550 111 HILL ROAD PO BOX 395 SE DECISION MADE: 03-DEC-10 DOUGLASSVILLE PA 19818 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOSWORTH AIR POLISHER HARRY J. BOSWORTH CO. 510(k) NO: K100731(TRADITIONAL) ATTN: GARY CHUVEN PHONE NO : 847 679 3400 7227 NORTH HAMLIN AVE. SE DECISION MADE: 03-DEC-10 SKOKIE IL 60076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES BONART CO. LTD. 510(k) NO: K100785(TRADITIONAL) ATTN: ERIC L ONG PHONE NO : 909 594 8066 398 S. LEMON CREEK DR. SUITE G SE DECISION MADE: 03-DEC-10 WALNUT CA 91789 510(k) STATEMENT DEVICE: BIOPRO POLAR HEAD BIOPRO, INC. 510(k) NO: K100761(TRADITIONAL) ATTN: DAVID MRAK PHONE NO : 810 982 7777 17 SEVENTEENTH ST. SE DECISION MADE: 03-DEC-10 PORT HURON MI 48060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STELLATE GRIDVIEW EXCEL-TECH LTD. (XLTEK) 510(k) NO: K100126(ABBREVIATED) ATTN: GOLDY SINGH PHONE NO : 905 829 5300 2568 BRISTOL CIR. SE DECISION MADE: 03-DEC-10 OAKVILLE, ONTARIO CA L6H 5S1 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE SENTEC AG 510(k) NO: K101690(TRADITIONAL) ATTN: STEPHEN H GORSKI PHONE NO : 262 594 2114 S65 W35739 PIPER ROAD SE DECISION MADE: 03-DEC-10 EAGLE WI 53119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREMIO 10 MOXA SEDATELEC 510(k) NO: K101267(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720 962 5412 5401 S. COTTONWOOD COURT SE DECISION MADE: 03-DEC-10 GREENWOOD VILLAGE CO 80121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM BIO-RAD LABORATORIES 510(k) NO: K092587(TRADITIONAL) ATTN: PATRICIA KLIMLEY PHONE NO : 510 741 6263 5500 E. SECOND ST SE DECISION MADE: 03-DEC-10 BENICIA CA 94510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER ZIMMER, INC. 510(k) NO: K101229(TRADITIONAL) ATTN: REBECCA BROOKS PHONE NO : 574 371 8033 P.O. BOX 708 SE DECISION MADE: 03-DEC-10 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHYSIOFLOW ENDURO VASOCOM, INC. 510(k) NO: K103283(SPECIAL) ATTN: JAMES GUNNERSON PHONE NO : 215 826 9998 2014 FORD RD., UNIT G SE DECISION MADE: 03-DEC-10 BRISTOL PA 19007 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENCODE PATIENT SPECIFIC ABUTMENT BIOMET 3I, INC. 510(k) NO: K102209(TRADITIONAL) ATTN: SIMEON SIMONE PHONE NO : 561 776 6831 4555 RIVERSIDE DR. SE DECISION MADE: 03-DEC-10 PALM BEACH GARDENS FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIANCE ENDOSCOPE PROCESSING SYSTEM STERIS CORPORATION 510(k) NO: K102244(TRADITIONAL) ATTN: ROBERT F SULLIVAN PHONE NO : 440 392 7695 5960 HEISLEY ROAD SE DECISION MADE: 03-DEC-10 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS ZIMMER, INC. 510(k) NO: K101730(TRADITIONAL) ATTN: BRADLEY STRASSER PHONE NO : 574 372 4780 P.O. BOX 708 SE DECISION MADE: 03-DEC-10 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KLASSIC HD HIP SYSTEM TOTAL JOINT ORTHOPEDICS, INC. 510(k) NO: K100445(TRADITIONAL) ATTN: KIT CARIQUITAN PHONE NO : 408 400 0856 155-A MOFFETT PARK DRIVE SUITE 210SE DECISION MADE: 03-DEC-10 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLEURAFLOW CATHETER SYSTEM CLEAR CATHETER SYSTEMS 510(k) NO: K093565(TRADITIONAL) ATTN: MONICA DOUGHERTY PHONE NO : 210 957 2083 901 KING ST., SUITE 200 SE DECISION MADE: 03-DEC-10 ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DMP PIT & FISSURE SEALANT DMP LTD 510(k) NO: K102252(TRADITIONAL) ATTN: DIMITRIS PRANTSIDIS PHONE NO : 003 022 99023041 KALYVION AVENUE MARKOPOULO INDUSTRSE DECISION MADE: 03-DEC-10 MARKOPOULO, ATTIKI GR 19003 510(k) STATEMENT DEVICE: VERTEX RAPID SIMPLIFIED VERTEX-DENTAL B.V. 510(k) NO: K102654(TRADITIONAL) ATTN: WILLIAM GREENROSE PHONE NO : 603 369 3550 22 RIVER ROAD SE DECISION MADE: 03-DEC-10 CLAREMONT NH 03743 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT CENDRES & METAUX SA 510(k) NO: K102382(SPECIAL) ATTN: TANJA BONGNI PHONE NO : 415 836 02000 RUE DE BOUJEAN 122 SE DECISION MADE: 03-DEC-10 BIEL/BIENNE SZ 2501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATRIOT TRANSCONTINENTAL M SPACERS GLOBUS MEDICAL, INC. 510(k) NO: K102313(TRADITIONAL) ATTN: KELLY J BAKER PHONE NO : 610 930 1800 2560 GENERAL ARMISTEAD AVE. VALLEYSE DECISION MADE: 03-DEC-10 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P HASS CORP. 510(k) NO: K102305(TRADITIONAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 844 2612 2341 W. CRESCENT AVE. #3 SE DECISION MADE: 03-DEC-10 ANAHEIM CA 92801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERETE LOCKING BONE PLATE SYSTEM II MERETE MEDICAL GMBH 510(k) NO: K102688(TRADITIONAL) ATTN: EMMANUEL ANAPLIOTIS PHONE NO : 914 967 1532 49 PURCHASE STREET SE DECISION MADE: 03-DEC-10 RYE NY 10580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IROOT FS INNOVATIVE BIOCERAMIX INC. 510(k) NO: K102867(SPECIAL) ATTN: QUANZU YANG PHONE NO : 604 221 6800 1628 WEST 75TH AVE. SE DECISION MADE: 03-DEC-10 VANCOUVER, BC CA V6P 6G2 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL MEDTRONIC INC. 510(k) NO: K103314(SPECIAL) ATTN: JEFFREY L KOLL PHONE NO : 763 514 9842 8200 CORAL SEA STREET NE MS MV S11SE DECISION MADE: 03-DEC-10 MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PC ECG EDAN INSTRUMENTS, INC. 510(k) NO: K102854(SPECIAL) ATTN: YUE QIUHONG (TRACY) PHONE NO : 867 552 6899197 NANHAI ROAD 1019# NANSHEN SE DECISION MADE: 03-DEC-10 SHENZHEN, GUANGDONG CH 518067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMMA-BSM; BETA-BSM; EQUIVABONE ETEX CORPORATION 510(k) NO: K102812(SPECIAL) ATTN: CHRISTOPHER KLACZYK PHONE NO : 617 817 6342 38 SIDNEY STREET SE DECISION MADE: 03-DEC-10 CAMBRIDGE MA 02139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS BIOMEDICAL DIAGNOSTICS (BMD) SA 510(k) NO: K102607(TRADITIONAL) ATTN: COURIVAUD CHRISTELLE PHONE NO : 331 646 21012 ACTIPOLE 25 4-6 BLD DE BEAUBOURG SE DECISION MADE: 03-DEC-10 MARNE LA VALLEE CEDEX 2 FR 7743510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 POREX SURGICAL, INC. 510(k) NO: K101835(TRADITIONAL) ATTN: STEPHANIE FULLARD PHONE NO : 678 479 1758 15 DART RD. SE DECISION MADE: 03-DEC-10 NEWNAN GA 30265 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRODESSE PROADENO GEN-PROBE PRODESSE, INC 510(k) NO: K102952(TRADITIONAL) ATTN: EMILY ZIELGER PHONE NO : 262 953 8421 W229 N1870 WESTWOOD DR SE DECISION MADE: 03-DEC-10 WAUKESHA WI 53186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE HEMOSTASIS, LLC 510(k) NO: K102459(TRADITIONAL) ATTN: BERNARD HORWATH PHONE NO : 651 855 1466 5000 TOWNSHIP PARKWAY SE DECISION MADE: 03-DEC-10 ST. PAUL MN 55110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYOPETTE MID-ATLANTIC DIAGNOSTICS, INC. 510(k) NO: K100596(TRADITIONAL) ATTN: ELISA D HARVEY PHONE NO : 301 774 0511 18905 CELEBRITY LANE SE DECISION MADE: 06-DEC-10 SANDY SPRING MD 20860 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GC AADVA IMPLANT SYSTEM GC AMERICA, INC. 510(k) NO: K093749(ABBREVIATED) ATTN: CARL JENKINS PHONE NO : 874 234 7500 10 E. SCRANTON AVENUE SUITE 201 SE DECISION MADE: 06-DEC-10 LAKE BLUFF IL 60044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICON MOGEN CLAMP MEDICON, E.G. 510(k) NO: K100916(TRADITIONAL) ATTN: JOACHIM SCHMID PHONE NO : 497 462 2009 GANSACKER 15 SE DECISION MADE: 06-DEC-10 TUTTLINGEN GM D-78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM HARVEST TECHNOLOGIES, CORP. 510(k) NO: K103340(SPECIAL) ATTN: JOHN D BONASERA PHONE NO : 508 732 7500 40 GRISSOM RD, SUITE 100 SE DECISION MADE: 06-DEC-10 PLYMOUTH MA 02360 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVERCROSS 0.035 OTW PTA DILATION CATHETER EV3 INC 510(k) NO: K103322(TRADITIONAL) ATTN: DAVID WORRELL, MS, RAC PHONE NO : 763 398 7344 3033 CAMPUS DRIVE SE DECISION MADE: 06-DEC-10 PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH ROCHE DIAGNOSTICS 510(k) NO: K103099(TRADITIONAL) ATTN: SUSAN HOLLANDBECK PHONE NO : 317 521 3380 9115 HAGUE ROAD PO BOX 50416 SE DECISION MADE: 06-DEC-10 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 EDWARDS LIFESCIENCES, LLC. 510(k) NO: K100739(TRADITIONAL) ATTN: PATRICIA MILBANK PHONE NO : 949 250 2603 ONE EDWARDS WAY SE DECISION MADE: 07-DEC-10 IRVINE CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M EDWARDS LIFESCIENCES, LLC. 510(k) NO: K100709(TRADITIONAL) ATTN: PATRICIA MILBANK, JD PHONE NO : 949 250 2603 ONE EDWARDS WAY SE DECISION MADE: 07-DEC-10 IRVINE CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S 100 PEDICLE SCREW SYSTEM RENOVIS SURGICAL TECHNOLOGIES, LLC510(k) NO: K101682(TRADITIONAL) ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD SE DECISION MADE: 07-DEC-10 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SKELETAL DYNAMICS STERILIZATION TRAYS SKELETAL DYNAMICS, LLC 510(k) NO: K102103(TRADITIONAL) ATTN: ANA M ESCAGEDO PHONE NO : 305 596 7585 8905 SW 87 AVENUE, SUITE 201 SE DECISION MADE: 07-DEC-10 MIAMI FL 33176 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIDERA DIASEND SYSTEM AIDERA AB 510(k) NO: K101806(TRADITIONAL) ATTN: ANDERS SONESSON PHONE NO : 46 31 7411785 MEDICINAREGATAN 8A SE DECISION MADE: 07-DEC-10 GOTEBORG SW SE 413 46 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARMANDA 14 PTA CATHETER ABBOTT VASCULAR INC. 510(k) NO: K102705(TRADITIONAL) ATTN: LAARNI RICAFORT PHONE NO : 408 845 0688 3200 LAKESIDE DRIVE SE DECISION MADE: 07-DEC-10 SANTA CLARA CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICAL MAGNETIC TAPE RECORDER WPR MEDICAL AS 510(k) NO: K102111(TRADITIONAL) ATTN: CONSTANCE G BUNDY PHONE NO : 763 574 1976 435 RICE CREEK TERRACE SE DECISION MADE: 07-DEC-10 FRIDLEY MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUMOVENT GRAPHNET MODEL 3179L1V TECME S.A. 510(k) NO: K101401(TRADITIONAL) ATTN: RAYMOND KELLY PHONE NO : 603 595 0095 56B SHADOWBROOK DRIVE SE DECISION MADE: 07-DEC-10 HUDSON NH 03051 510(k) STATEMENT DEVICE: VIPER SYSTEM, EXPEDIUM SYSTEM DEPUY SPINE, INC. 510(k) NO: K101993(SPECIAL) ATTN: FRANK JURCZAK PHONE NO : 508 828 3288 325 PARAMOUNT DR. SE DECISION MADE: 07-DEC-10 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRONEX DIREX SYSTEMS CORP. 510(k) NO: K102765(TRADITIONAL) ATTN: LARISA GERSHTEIN PHONE NO : 888 874 7837 437 TURNPIKE ST. SE DECISION MADE: 07-DEC-10 CANTON MA 02021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCOS INTERLOCKING DISTAL STEMS BIOMET MANUFACTURING CORP. 510(k) NO: K100469(TRADITIONAL) ATTN: BECKY EARL PHONE NO : 574 267 6639 56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 07-DEC-10 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPACELABS MEDICAL PATIENT MONITORS SPACELABS MEDICAL INC. 510(k) NO: K102422(SPECIAL) ATTN: DAVID J GERAGHTY PHONE NO : 425 657 7200 5150 220TH AVE SE SE DECISION MADE: 07-DEC-10 ISSAQUAH WA 98029 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES HOWMEDICA OSTEONICS CORP DBA STRYK510(k) NO: K102282(TRADITIONAL) ATTN: STEPHANIE FITTS PHONE NO : 201 831 5405 325 CORPORATE DRIVE SE DECISION MADE: 07-DEC-10 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201 NIHON KOHDEN CORP. 510(k) NO: K102376(SPECIAL) ATTN: STEVE GEERDES PHONE NO : 949 580 1555 90 ICON STREET SE DECISION MADE: 07-DEC-10 FOOTHILL RANCH CA 92610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM SUSPENSION ORTHOPAEDIC SOLUTIONS, 510(k) NO: K102095(TRADITIONAL) ATTN: CURTIS RAYMOND PHONE NO : 203 922 0105 80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 07-DEC-10 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEMA-ST, MODEL V1.0.2 NERVOMATRIX LTD 510(k) NO: K100668(TRADITIONAL) ATTN: DAN LAOR PHONE NO : 972 482 46632 SIRENI 6 SE DECISION MADE: 08-DEC-10 HAIFA IS 32972 510(k) STATEMENT DEVICE: TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM TANGO3, LLC 510(k) NO: K093641(TRADITIONAL) ATTN: LORI HOLDER PHONE NO : 817 368 6179 141A CITIZENS BLVD SE DECISION MADE: 08-DEC-10 SIMPSONVILLE KY 40067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD MAQUET CARDIOPULMONARY AG 510(k) NO: K101153(TRADITIONAL) ATTN: KATRIN SCHWENKGLENKS PHONE NO : 497 478 9210 HECHINGER STRASSE 38 SE DECISION MADE: 08-DEC-10 HIRRLINGEN GM 72145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIGEN TOTAL KNEE SYSTEM U&I CORP. 510(k) NO: K102367(TRADITIONAL) ATTN: GYEONG-JE KWON PHONE NO : 823 185 20102 529-1 YONGHYUN-DONG SE DECISION MADE: 08-DEC-10 EUIJUNGBU, KYUNGGI-DO KS 480-05510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER MANUKA MEDICAL LIMITED 510(k) NO: K102659(TRADITIONAL) ATTN: JAMES SMITH PHONE NO : 949 340 7261 29442 POINTE ROYALE SE DECISION MADE: 08-DEC-10 LAGUNA NIGUEL CA 92677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEEKER CROSSING SUPPORT CATHETER BARD PERIPHERAL VASCULAR, INC. 510(k) NO: K103367(TRADITIONAL) ATTN: CANDACE WADE PHONE NO : 480 303 2662 1625 WEST 3RD ST. SE DECISION MADE: 08-DEC-10 TEMPE AZ 85280 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PRUITT CAROTID KIT LEMAITRE VASCULAR, INC. 510(k) NO: K103356(SPECIAL) ATTN: VIC ZHANG PHONE NO : 781 221 2266 63 2ND AVENUE SE DECISION MADE: 08-DEC-10 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS 3M COMPANY 510(k) NO: K101910(TRADITIONAL) ATTN: SUZANNE LEUNG PHONE NO : 651 575 8052 3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 08-DEC-10 ST. PAUL MN 55133 3275 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM SUSPENSION ORTHOPAEDIC SOLUTIONS, 510(k) NO: K102143(TRADITIONAL) ATTN: JOSEPH AZARY PHONE NO : 203 922 0105 80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 08-DEC-10 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AURA SDI LIMITED 510(k) NO: K102984(TRADITIONAL) ATTN: RUTH EZEKIEL PHONE NO : 613 872 77111 3-13 BRUNSDON STREET SE DECISION MADE: 08-DEC-10 BAYSWATER, VICTORIA AS 3153 510(k) STATEMENT DEVICE: HYDROCOLOR 5 CASCADES DEVICE CONSULTING ASSOCIA510(k) NO: K102739(TRADITIONAL) ATTN: GERALD W SHIPPS PHONE NO : 541 389 5935 19379 BLUE LAKE LOOP SE DECISION MADE: 08-DEC-10 BEND OR 97702 1923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI MEDTRADE PRODUCTS LTD. 510(k) NO: K102965(TRADITIONAL) ATTN: JONATHAN D RANFIELD PHONE NO : 440 127 0500019 ELECTRA HOUSE CREWE BUSINESS PARK SE DECISION MADE: 08-DEC-10 CHESHIRE UK CW1 6GL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULISA DSDNA ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. 510(k) NO: K101319(TRADITIONAL) ATTN: KEVIN LAWSON PHONE NO : 716 691 0091 60 PINEVIEW DR. SE DECISION MADE: 09-DEC-10 BUFFALO NY 14228 2120 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: HIP SEXTANT INSTRUMENT SYSTEM SURGICAL PLANNING ASSOCIATES 510(k) NO: K093491(TRADITIONAL) ATTN: JOSEPH AZARY PHONE NO : 203 922 0105 80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 09-DEC-10 MEDFORD MA 02155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELF RETAINING SOFT TISSUE RETRACTOR KOROS USA, INC. 510(k) NO: K101609(TRADITIONAL) ATTN: TIBOR KOROS PHONE NO : 805 529 0825 610 FLINN AVE. SE DECISION MADE: 09-DEC-10 MOORPARK CA 93021 510(k) STATEMENT DEVICE: 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES SYNTHES (USA) 510(k) NO: K102694(TRADITIONAL) ATTN: CHRISTOPHER HACK, ESQ PHONE NO : 610 719 6940 1301 GOSHEN PKWY. SE DECISION MADE: 09-DEC-10 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS MEMTEC CORP. 510(k) NO: K102723(TRADITIONAL) ATTN: DENNIS GARBOSKI PHONE NO : 603 893 8080 68 STILES RD. UNIT D SE DECISION MADE: 09-DEC-10 SALEM NH 03079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOBEL ACTIVE 3.0 NOBEL BIOCARE AB 510(k) NO: K102436(TRADITIONAL) ATTN: HERBERT CRANE PHONE NO : 714 282 5074 15 BOHUSGATAN, P.O. BOX 5190 SE DECISION MADE: 09-DEC-10 GOTEBORG SW S-402 26 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 PREMIUM PLUS INTERNATIONAL LIMITED510(k) NO: K100854(TRADITIONAL) ATTN: DENNIS NG PHONE NO : 852 276 13211 33 WANG YIP STREET WEST YUEN LONG SE DECISION MADE: 09-DEC-10 HONG KONG CH 510(k) STATEMENT DEVICE: KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON MEDICAL CO., LTD. 510(k) NO: K102609(ABBREVIATED) ATTN: LIU YI PHONE NO : 86 22 60526161 # 3 JIN PING STREET, YA AN RD NANKSE DECISION MADE: 09-DEC-10 TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM SORIN GROUP DEUTSCHLAND GMBH 510(k) NO: K101046(TRADITIONAL) ATTN: ROSINA ROBINSON PHONE NO : 508 643 0434 49 PLAIN STREET SE DECISION MADE: 09-DEC-10 NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULLINS-X PTV CATHETER NUMED, INC. 510(k) NO: K102473(TRADITIONAL) ATTN: NICHELLE LAFLESH PHONE NO : 315 328 4491 2880 MAIN ST. SE DECISION MADE: 09-DEC-10 HOPKINTON NY 12965 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS CHANG GUNG MEDICAL TECHNOLOGY CO.,510(k) NO: K102989(TRADITIONAL) ATTN: BOB LEIKER PHONE NO : 925 556 1302 7263 CRONIN CIRCLE SE DECISION MADE: 09-DEC-10 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREVISION HIP SYSTEM WITH RECON RING AESCULAP IMPLANT SYSTEMS, LLC 510(k) NO: K102424(TRADITIONAL) ATTN: KATHY A RACOSKY PHONE NO : 610 984 9291 3773 CORPORATE PARKWAY SE DECISION MADE: 09-DEC-10 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 KEELER INSTRUMENTS, INC. 510(k) NO: K093298(TRADITIONAL) ATTN: EUGENE VAN ARSDALE PHONE NO : 610 353 4350 456 PKWY. SE DECISION MADE: 10-DEC-10 BROOMALL PA 19008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD TEI BIOSCIENCES INC. 510(k) NO: K100261(ABBREVIATED) ATTN: KENNETH JAMES PHONE NO : 617 268 1616 7 ELKINS ST. SE DECISION MADE: 10-DEC-10 BOSTON MA 02127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABL837 FLEX ANALYZER RADIOMETER MEDICAL APS 510(k) NO: K100777(ABBREVIATED) ATTN: ROWENA JANSSON PHONE NO : 45 381 73852 AKANDEVEJ 21 SE DECISION MADE: 10-DEC-10 BRONSHOJ DA DK-2700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPIDVIT BLAST, RAPIDWARM BLAST VITROLIFE SWEDEN AB 510(k) NO: K101003(TRADITIONAL) ATTN: KJELL KJORK PHONE NO : 463 172 18077 BOX 9080 SE DECISION MADE: 10-DEC-10 SE-400 92 GOTEBORG SW 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH ETHICON ENDO-SURGERY, INC. 510(k) NO: K101520(TRADITIONAL) ATTN: RUTH WOOD PHONE NO : 513 337 3566 4545 CREEK ROAD ML#132 SE DECISION MADE: 10-DEC-10 CINCINATTI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIXI PEDIATRIC MASK RESMED LTD. 510(k) NO: K102224(TRADITIONAL) ATTN: DAVID D'CRUZ PHONE NO : 858 836 5984 9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 10-DEC-10 SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY ATTUNE KNEE SYSTEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K101433(TRADITIONAL) ATTN: KATHY BOGGS PHONE NO : 574 371 4945 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 10-DEC-10 WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENESYS SPINE INTERBODY FUSION SYSTEM GENESYS SPINE 510(k) NO: K103034(TRADITIONAL) ATTN: JOSH KAUFMANN PHONE NO : 512 560 3446 1250 CAPITAL OF TEXAS HWY SO. BUILSE DECISION MADE: 10-DEC-10 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCUCOMP THERMOTEK, INC. 510(k) NO: K103247(TRADITIONAL) ATTN: NIRAN BALACHANDRAN PHONE NO : 972 874 4900 1200 LAKESIDE PARKWAY #200 SE DECISION MADE: 10-DEC-10 FLOWER MOUND TX 75028 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INFUSION SETS HOSPIRA, INC. 510(k) NO: K103344(SPECIAL) ATTN: REBECCA ANDERSEN PHONE NO : 224 212 5316 275 NORTH FIELD DR. SE DECISION MADE: 10-DEC-10 LAKE FOREST IL 60045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RII INFRARED EAR THERMOMETER, RADIANT INNOVATION, INC. 510(k) NO: K102187(SPECIAL) ATTN: JAMES HUANG PHONE NO : 886 361 11666 1F,NO. 3,INDUSTRIAL E. 9TH RD SCIESE DECISION MADE: 10-DEC-10 HSINCHU TW 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS KIMBERLY CLARK CORPORATION 510(k) NO: K103311(SPECIAL) ATTN: CHERYL SANZARE PHONE NO : 770 587 7131 2100 WINCHESTER ROAD SE DECISION MADE: 10-DEC-10 NEENAH WI 54956 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INZONE DETACHMENT SYSTEM BOSTON SCIENTIFIC CORP. 510(k) NO: K103008(SPECIAL) ATTN: JAMES LEATHLEY PHONE NO : 510 440 7836 47900 BAYSIDE PARKWAY SE DECISION MADE: 10-DEC-10 FREMONT CA 94538 6515 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM HAEMONETICS CORP. 510(k) NO: K101907(TRADITIONAL) ATTN: GREG CALDER PHONE NO : 781 356 9538 400 WOOD RD. P.O. BOX 9114 SE DECISION MADE: 10-DEC-10 BRAINTREE MA 02184 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX SPINE SYSTEM W/ COCR RODS SPINECRAFT LLC 510(k) NO: K102488(SPECIAL) ATTN: AMI AKALLAL-ASAAD PHONE NO : 708 531 9700 2215 ENTERPRISE DRIVE SUITE 1504 SE DECISION MADE: 10-DEC-10 WESTCHESTER IL 60154 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APTUS 1.5 TRILOCK MEDARTIS AG 510(k) NO: K102537(SPECIAL) ATTN: KEVIN A THOMAS PHONE NO : 858 792 1235 11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 10-DEC-10 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, LIMA-LTO S.P.A. 510(k) NO: K100858(TRADITIONAL) ATTN: CHERYL HASTINGS PHONE NO : 574 527 4220 PO BOX 696 SE DECISION MADE: 10-DEC-10 WINONA LAKE IN 46590 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WILLOW/ELM PTA BALLOON DILATATION CATHETER CREAGH MEDICAL LTD 510(k) NO: K102645(TRADITIONAL) ATTN: MAUREEN O'CONNELL PHONE NO : 978 207 1245 5 TIMBER LANE SE DECISION MADE: 10-DEC-10 NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS THAYER MEDICAL CORP. 510(k) NO: K102658(SPECIAL) ATTN: JAMES M STRICKLAND PHONE NO : 520 790 5393 4575 SOUTH PALO VERDE RD., SUITE 3SE DECISION MADE: 10-DEC-10 TUCSON AZ 85714 1961 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTRO INTERSTITIAL SCAN L.D. TECHNOLOGY, LLC 510(k) NO: K102166(TRADITIONAL) ATTN: RICHARD CLEMENT PHONE NO : 305 594 2145 11459 NW 34 STREET SE DECISION MADE: 10-DEC-10 MIAMI FL 33178 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED DRAEGER MEDICAL AG & CO. KG 510(k) NO: K102618(TRADITIONAL) ATTN: JOYCE KILROY PHONE NO : 215 660 2626 3135 QUARRY ROAD SE DECISION MADE: 10-DEC-10 TELFORD PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTA CYBER TM 150W QUANTA SYSTEM SPA 510(k) NO: K102749(TRADITIONAL) ATTN: ISABELLA CARRER PHONE NO : 390 331 376797 VIA IV NOVEMBRE, 116 SE DECISION MADE: 10-DEC-10 SOLBIATE OLONA, VA IT 21058 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FRONTIER DEVICES NEURO SYSTEM FOLSOM METAL PRODUCTS, INC. 510(k) NO: K100205(TRADITIONAL) ATTN: DON PETERSON PHONE NO : 205 733 0901 153 CAHABA VALLEY PKWY. SE DECISION MADE: 13-DEC-10 PELHAM AL 35124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUSTAIN SPACE MAINTENANCE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K100779(TRADITIONAL) ATTN: MICHELLE OBENAUER PHONE NO : 901 399 2117 1800 PYRAMID PLACE SE DECISION MADE: 13-DEC-10 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES BENLAN, INC. 510(k) NO: K100700(TRADITIONAL) ATTN: CHERYL BROWN PHONE NO : 905 829 5004 2760 BRIGHTON RD. SE DECISION MADE: 13-DEC-10 OAKVILLE, ONTARIO CA L6H 5T4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR INSTITUT STRAUMANN AG 510(k) NO: K101465(TRADITIONAL) ATTN: JANET KAY PHONE NO : 978 747 2575 60 MINUTEMAN ROAD SE DECISION MADE: 13-DEC-10 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TREVAIR CHAIR ADULT PATMONT MOTOR WERKS, INC. 510(k) NO: K102061(TRADITIONAL) ATTN: STEVEN J PATMONT PHONE NO : 775 782 0113 2220 MERIDIAN BLVD SE DECISION MADE: 13-DEC-10 MINDEN NV 89423 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL THERMOMETER; DIGITAL THERMOMETER INTERNATIONAL REGULATORY CONSULTAN510(k) NO: K102718(TRADITIONAL) ATTN: JACOB CHANG PHONE NO : 886 4 22465396 16F-2(16A), SEC. 2 CHONG DE RD SE DECISION MADE: 13-DEC-10 TAICHUNG CH 406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS SMITH & NEPHEW ENDOSCOPY, INC. 510(k) NO: K102660(TRADITIONAL) ATTN: KATHLEEN SOLOMON PHONE NO : 978 749 1605 150 MINUTEMAN ROAD SE DECISION MADE: 13-DEC-10 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM EXACTECH, INC. 510(k) NO: K103419(SPECIAL) ATTN: PATRICK HUGHES PHONE NO : 352 377 1140 2320 N.W. 66TH COURT SE DECISION MADE: 13-DEC-10 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCUTRAK PTA DILATATION CATHETER C. R. BARD, INC. 510(k) NO: K103459(TRADITIONAL) ATTN: CANDACE WADE PHONE NO : 480 303 2662 1625 W 3RD STREET SE DECISION MADE: 13-DEC-10 TEMPE AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TRABECULAR METAL TIBIAL CONE AUGMENTS ZIMMER TRABECULAR METAL TECHNOLOGY510(k) NO: K102896(TRADITIONAL) ATTN: KATHLEEN RUTHERFORD PHONE NO : 973 576 0139 10 POMEROY RD. SE DECISION MADE: 13-DEC-10 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLORED) HEZE JUXINYUAN FOOD CO., LTD 510(k) NO: K102976(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 RM 1606 BLD 1 JIAN XIANG YUAN N209SE DECISION MADE: 13-DEC-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITAL SUTURES, SUTUREX, CIRUGIA PERUANA UNILENE S.A.C. 510(k) NO: K100780(TRADITIONAL) ATTN: KEVIN WALLS, RAC PHONE NO : 720 962 5412 5401 S. COTTONWOOD CT. SE DECISION MADE: 14-DEC-10 GREENWOOD VILLAGE CO 80121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFECT MODEL VER 1.0 MEDIC VISION BRAIN TECHNOLOGIES LT510(k) NO: K100372(TRADITIONAL) ATTN: DAN LAOR PHONE NO : 972 482 46632 6 SIRENI SE DECISION MADE: 14-DEC-10 HAIFA IS 32972 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INBONE TOTAL ANKLE SYSTEM MODEL 200347902 WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K103374(SPECIAL) ATTN: KELSEY LEE PHONE NO : 901 290 5909 5677 AIRLINE RD. SE DECISION MADE: 14-DEC-10 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMFORT STANDING WHEELCHAIR, HERO SERIES COMFORT ORTHOPEDIC CO. LTD. 510(k) NO: K102734(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 2064 TAMARIN DRIVE SE DECISION MADE: 14-DEC-10 COLUMBUS OH 43235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMMETRY SACROILIAC JOINT FUSION SYSTEM ZYGA TECHNOLOGY, INC. 510(k) NO: K102907(TRADITIONAL) ATTN: DIANE BRINZA PHONE NO : 612 455 1061 700 10TH AVENUE SOUTH, SUITE 400 SE DECISION MADE: 14-DEC-10 MINNEAPOLIS MN 55415 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECIALTY ASSAYED CONTROL-2 HELENA LABORATORIES 510(k) NO: K100103(TRADITIONAL) ATTN: PATRICIA FRANKS PHONE NO : 409 842 3714 1530 LINDBERGH DR. P.O. BOX 752 SE DECISION MADE: 15-DEC-10 BEAUMONT TX 77704 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTIVON TULLE CALIDAD SOLUTIONS, INC. 510(k) NO: K101118(TRADITIONAL) ATTN: JOHN BILLINGS PHONE NO : 206 575 7762 22433 72 AVENUE S SE DECISION MADE: 15-DEC-10 KENT WA 98032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 PHADIA AB 510(k) NO: K100999(TRADITIONAL) ATTN: MARTIN MANN PHONE NO : 269 492 1957 4169 COMMERCIAL AVENUE SE DECISION MADE: 15-DEC-10 PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201 TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K101012(TRADITIONAL) ATTN: TELING HSU PHONE NO : 886 266 258188 3F, 5F, NO 127 WUGONG 2ND RD WUGU SE DECISION MADE: 15-DEC-10 TAIPEI COUNTY TW 248 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 SEPPIM S.A.S. 510(k) NO: K100525(TRADITIONAL) ATTN: DEBRA HUTSON PHONE NO : 425 482 5174 21720 23RD DR SE SUITE 150 SE DECISION MADE: 15-DEC-10 BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT ANGIODYNAMICS, INC. 510(k) NO: K102796(TRADITIONAL) ATTN: TERI JUCKETT PHONE NO : 518 795 1142 603 QUEENSBURY AVE. SE DECISION MADE: 15-DEC-10 QUEENSBURY NY 12804 510(k) STATEMENT DEVICE: EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 VITAL DIAGNOSTICS (MANUFACTURING) 510(k) NO: K100060(TRADITIONAL) ATTN: MELITA LAMBIRIS PHONE NO : 613 879 36300 189-199 BROWNS RD SE DECISION MADE: 15-DEC-10 NOBLE PARK, VICTORIA AS 3174 510(k) STATEMENT DEVICE: DEPUY GLOBAL UNITE SHOULDER SYSTEM DEPUY (IRELAND) 510(k) NO: K101996(TRADITIONAL) ATTN: RHONDA MYER PHONE NO : 574 371 4927 LOUGHBEG RINGASKIDDY SE DECISION MADE: 15-DEC-10 CO. CORK EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTOURS LAPIDUS PLATING SYSTEM ORTHOFIX INC. 510(k) NO: K102201(TRADITIONAL) ATTN: MARY BIGGERS PHONE NO : 972 824 4624 1720 BRAY CENTRAL DR. SE DECISION MADE: 15-DEC-10 MCKINNEY TX 75069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K102956(SPECIAL) ATTN: SHANNON SCOTT PHONE NO : 210 515 4368 6203 FARINON DRIVE SE DECISION MADE: 15-DEC-10 SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER BIOLITEC, INC. 510(k) NO: K102755(TRADITIONAL) ATTN: NANCY FOLEY PHONE NO : 413 525 0600 515 SHAKER RD. SE DECISION MADE: 16-DEC-10 EAST LONGMEADOW MA 01028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM SYNTHES (USA) 510(k) NO: K093299(TRADITIONAL) ATTN: ALAN T HALEY PHONE NO : 484 356 9763 1301 GOSHEN PKWY. SE DECISION MADE: 16-DEC-10 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE MEDTRONIC INC. 510(k) NO: K100646(TRADITIONAL) ATTN: JEFFREY L KOLL PHONE NO : 763 514 9842 7611 NORTHLAND DRIVE SE DECISION MADE: 16-DEC-10 MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301 VASCULAR SOLUTIONS, INC. 510(k) NO: K101659(TRADITIONAL) ATTN: MATT NIENSTEDT PHONE NO : 763 656 4300 6464 SYCAMORE COURT SE DECISION MADE: 16-DEC-10 MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EUROMI EVA SP6 EUROMI SA 510(k) NO: K101413(TRADITIONAL) ATTN: CURTIS RAYMOND PHONE NO : 203 922 0105 80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 16-DEC-10 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GNR TRAFFIC LIGHT PNA FISH ADVANDX, INC. 510(k) NO: K101558(TRADITIONAL) ATTN: HENRIK STENDER PHONE NO : 781 376 0009 400 TRADECENTER SUITE 6990 SE DECISION MADE: 16-DEC-10 WOBURN MA 01801 510(k) STATEMENT DEVICE: VU CPOD INTERVERTEBRAL BODU FUSION DEVICE MUSCULOSKELETAL CLINICAL REGULATOR510(k) NO: K101363(TRADITIONAL) ATTN: GLENN STIEGMAN PHONE NO : 202 552 5800 1331 H STREET NW, 12TH FLOOR SE DECISION MADE: 16-DEC-10 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDO FLIP CROSPON, LTD. 510(k) NO: K102214(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 16-DEC-10 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POSTERIOR LATERAL PLATES DEPUY ORTHOPAEDICS, INC. 510(k) NO: K103408(SPECIAL) ATTN: SUZANA OTANO PHONE NO : 305 269 6386 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 16-DEC-10 WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEAK PULSAR II GENERATOR MODEL PS100-102 PEAK SURGICAL, INC. 510(k) NO: K102029(SPECIAL) ATTN: LOIS NAKAYAMA PHONE NO : 650 331 8920 2464 EMBARCADERO WAY SE DECISION MADE: 16-DEC-10 PALO ALTO CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVITA WRIST TYPE BLOOD PRESSURE MONITOR AVITA CORPORATION 510(k) NO: K102624(TRADITIONAL) ATTN: JENNIFER REICH PHONE NO : 928 863 6340 2904 N. BOLDT DR. SE DECISION MADE: 16-DEC-10 FLAGSTAFF AZ 86001 510(k) STATEMENT DEVICE: NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM MEDYSSEY CO., LTD. 510(k) NO: K103147(SPECIAL) ATTN: PATRICK MOORE PHONE NO : 801 266 4811 6170 SOUTH 380 WEST SUITE 200 SE DECISION MADE: 16-DEC-10 MURRAY UT 84107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM CARDINAL HEALTH, INC. 510(k) NO: K103249(TRADITIONAL) ATTN: TATYANA BOGDAN PHONE NO : 847 887 2325 1430 WAUKEGAN ROAD SE DECISION MADE: 16-DEC-10 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GSP NEONATAL IRT KIT (3306-001U) WALLAC OY, SUBSIDIARY OF PERKINELM510(k) NO: K102419(TRADITIONAL) ATTN: SUSAN K HAMANN PHONE NO : 781 663 5872 940 WINTER STREET SE DECISION MADE: 16-DEC-10 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM C.R. BARD INC 510(k) NO: K102766(TRADITIONAL) ATTN: KETI SINO PHONE NO : 401 825 8575 100 CROSSINGS BOULEVARD SE DECISION MADE: 16-DEC-10 WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STIMPOD NMS450 NERVE STIMULATOR XAVANT TECHNOLOGY (PTY), LTD. 510(k) NO: K102084(TRADITIONAL) ATTN: B ROTHMAN PHONE NO : 271 275 59491 169 GARSFONTEIN ROAD ASHLEA GARDENSE DECISION MADE: 16-DEC-10 PRETORIA, GAUTENG SF 0081 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EXPEDIUM SPINE SYSTEM DEPUY SPINE, A JOHNSON & JOHNSON C510(k) NO: K102249(SPECIAL) ATTN: DAPHNEY GERMAIN PHONE NO : 508 880 8395 325 PARAMOUNT DRIVE SE DECISION MADE: 16-DEC-10 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE THEKEN SPINE LLC 510(k) NO: K102323(TRADITIONAL) ATTN: DALE DAVISON PHONE NO : 330 475 8600 1800 TRIPLETT BLVD. SE DECISION MADE: 16-DEC-10 AKRON OH 44306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIPI BLOCK VIPI INDUSTRIA,COMERCIO,EXPORTACAO510(k) NO: K102341(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720 962 5412 5401 S. COTTONWOOD COURT SE DECISION MADE: 16-DEC-10 GREENWOOD VILLAGE CO 80121 510(k) STATEMENT DEVICE: IBED WIRELESS WITH IBED AWARENESS STRYKER CORPORATION 510(k) NO: K103536(TRADITIONAL) ATTN: DIANE HORWITZ PHONE NO : 703 307 2921 3800 E. CENTRE AVE SE DECISION MADE: 16-DEC-10 PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: STRAUMANN MEMBRAGEL STRAUMANN USA (ON BEHALF OF INSTIT510(k) NO: K101956(TRADITIONAL) ATTN: JANET C KAY PHONE NO : 978 743 2575 60 MINUTEMAN ROAD SE DECISION MADE: 16-DEC-10 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HIGH PRESSURE SETS-400 PSI ICU MEDICAL, INC. 510(k) NO: K100576(TRADITIONAL) ATTN: TRACY BEST PHONE NO : 801 264 1332 4455 ATHERTON DRIVE SE DECISION MADE: 17-DEC-10 SALT LAKE CITY UT 84123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTO JEIL MEDICAL CORPORATION 510(k) NO: K101563(TRADITIONAL) ATTN: KIM SEONG NAM PHONE NO : 822 838 5517 1006 DIGITAL 2CHA VALLEY BYUCKSAN,SE DECISION MADE: 17-DEC-10 SEOUL KS 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REGIONAL OXIMETER NONIN MEDICAL, INC. 510(k) NO: K102715(TRADITIONAL) ATTN: LORI M MITCHELL PHONE NO : 763 577 3093 13700 1ST AVE. NORTH SE DECISION MADE: 17-DEC-10 PLYMOUTH MN 55441 5443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE PEAK SURGICAL, INC. 510(k) NO: K102709(SPECIAL) ATTN: AN NGUYEN PHONE NO : 650 331 3020 2464 EMBARCADERO WAY SE DECISION MADE: 17-DEC-10 PALO ALTO CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL SIEMENS CORP. 510(k) NO: K103360(TRADITIONAL) ATTN: ROSE T MARINELLI PHONE NO : 302 631 8805 500 GBC DRIVE MAILSTOP 514 P.O. BOSE DECISION MADE: 17-DEC-10 NEWARK DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION NIHON KOHDEN CORP. 510(k) NO: K102106(TRADITIONAL) ATTN: STEVE GEERDES PHONE NO : 949 580 1555 90 ICON STREET SE DECISION MADE: 17-DEC-10 FOOTHILL CA 92610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K103432(SPECIAL) ATTN: ROBERT CASARSA PHONE NO : 414 362 3063 8200 WEST TOWER AVENUE SE DECISION MADE: 17-DEC-10 MILWAUKEE WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER INOVO, INC. 510(k) NO: K103392(SPECIAL) ATTN: MICHAEL T DILDINE PHONE NO : 239 643 6577 2975 S. HORSESHOE DRIVE SUITE 600 SE DECISION MADE: 17-DEC-10 NAPLES FL 34104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939 HARDY DIAGNOSTICS 510(k) NO: K103538(TRADITIONAL) ATTN: WENDY HADLEY PHONE NO : 800 266 2222 1430 WEST MCCOY LN. SE DECISION MADE: 17-DEC-10 SANTA MARIA CA 93455 510(k) STATEMENT DEVICE: ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY STI MEDICAL SYSTEMS 510(k) NO: K090324(TRADITIONAL) ATTN: ROLF WOLTERS PHONE NO : 808 540 4728 733 BISHOP STREET SUITE 3100 SE DECISION MADE: 20-DEC-10 HONOLULU HI 96813 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES ZERO-P SYNTHES SPINE 510(k) NO: K093762(SPECIAL) ATTN: AMNON TALMOR PHONE NO : 610 719 5446 1302 WRIGHTS LANE EAST SE DECISION MADE: 20-DEC-10 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PT-MULTI-CALIBRATOR, MODEL OPAT07 DADE BEHRING, INC. 510(k) NO: K093848(TRADITIONAL) ATTN: RADAMES RIESGO PHONE NO : 305 480 7558 500 GBC DR, MAILSTOP 514 SE DECISION MADE: 20-DEC-10 NEWARK DE 19714 6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COWELL IMPLANT SYSTEM COWELLMEDI CO., LTD 510(k) NO: K100850(TRADITIONAL) ATTN: JOYCE BANG PHONE NO : 714 525 0114 325 N. PUENTE ST UNIT B SE DECISION MADE: 20-DEC-10 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INERTIA PEDICLE SCREW SYSTEM NEXXT SPINE LLC 510(k) NO: K101278(SPECIAL) ATTN: KAREN WARDEN PHONE NO : 440 729 8457 8202 SHERMAN ROAD SE DECISION MADE: 20-DEC-10 CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDURO KNEE SYSTEM AESCULAP IMPLANT SYSTEMS 510(k) NO: K101815(TRADITIONAL) ATTN: KATHY A RACOSKY PHONE NO : 610 984 9291 3773 CORPORATE PWKY. SE DECISION MADE: 20-DEC-10 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE NEOORTHO PRODUTOS ORTOPEDICOS S/A 510(k) NO: K102641(TRADITIONAL) ATTN: LINDA K SCHULZ PHONE NO : 858 791 1235 11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 20-DEC-10 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES YOUNGSHENGPLASTIC CO., LTD 510(k) NO: K103198(TRADITIONAL) ATTN: WU WEI PHONE NO : 86 373 2588628 NEW INDUSTRIAL PARK SE DECISION MADE: 20-DEC-10 XINCIANGCITY CH 453003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRELUDE II TOUNGE SUSPENSION SYSTEM SIESTA MEDICAL, INC. 510(k) NO: K103179(SPECIAL) ATTN: MICHAEL KOLBER PHONE NO : 408 505 6626 101 CHURCH STREET SUITE 3 SE DECISION MADE: 20-DEC-10 LOS GATOS CA 95030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RHEAD RADIAL HEAD EXTENDED STEMS SMALL BONE INNOVATIONS, INC. 510(k) NO: K102180(TRADITIONAL) ATTN: JAMES O'CONNOR PHONE NO : 215 428 1791 1380 S. PENNSYLVANIA AVE. SE DECISION MADE: 20-DEC-10 MORRISVILLE PA 19067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES ZIBO YUQUN NEW MATERIAL SCIENCE AN510(k) NO: K102724(TRADITIONAL) ATTN: FRANK LIU PHONE NO : 909 548 4828 12390 EST END AVE SE DECISION MADE: 20-DEC-10 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K102889(TRADITIONAL) ATTN: DOUGH THISTLETHWAITE PHONE NO : 330 425 1313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 20-DEC-10 TWINSBURG OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DANA REUSABLE TEST PACK FOR STEAM STERILIZATION DANA PRODUCTS, INC. 510(k) NO: K102761(TRADITIONAL) ATTN: HARRY BALA PHONE NO : 847 455 2881 7 COREY DR. SE DECISION MADE: 20-DEC-10 SOUTH BARRINGTON IL 60010 510(k) STATEMENT DEVICE: ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM ACE SURGICAL SUPPLY COMPANY INC. 510(k) NO: K102981(SPECIAL) ATTN: CAROL A HOUTS PHONE NO : 508 588 3100 1034 PEARL ST. SE DECISION MADE: 20-DEC-10 BROCKTON MA 02401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC, POWDER-FREE NITRILE EXAMINATION ZIBO YINGHAO MEDICAL PRODUCTS CO.,510(k) NO: K102593(TRADITIONAL) ATTN: FRANK LIU PHONE NO : 909 548 4828 12390 EAST END AVE SE DECISION MADE: 20-DEC-10 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TWISTCUT ENDOSORB SCREWS MERETE MEDICAL GMBH 510(k) NO: K102777(TRADITIONAL) ATTN: EMMANUEL ANAPLIOTIS PHONE NO : 914 967 1532 102 ALT LANKWITZ SE DECISION MADE: 20-DEC-10 BERLIN GM D-12247 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K102875(TRADITIONAL) ATTN: DONNA MILLISKY PHONE NO : 609 936 2454 311 ENTERPRISE DR. SE DECISION MADE: 20-DEC-10 PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE SUNMAX VIETNAM CO. LTD 510(k) NO: K101870(ABBREVIATED) ATTN: JIGAR SHAH PHONE NO : 516 482 9001 55 NORTHERN BLVD SUITE 200 SE DECISION MADE: 20-DEC-10 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK MEDACTA INTERNATIONAL, SA 510(k) NO: K103189(SPECIAL) ATTN: NATALIE J KENNEL PHONE NO : 858 705 0350 13721 VIA TRES VISTA SE DECISION MADE: 20-DEC-10 SAN DIEGO CA 92129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM SYNTHES (USA) 510(k) NO: K102656(TRADITIONAL) ATTN: ALAN T HALEY PHONE NO : 484 356 9763 1301 GOSHEN PKWY. SE DECISION MADE: 20-DEC-10 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMC PISTON SYRINGES INTERNATIONAL MEDSURG CONNECTION 510(k) NO: K102969(SPECIAL) ATTN: PETER KIM PHONE NO : 847 619 9926 935 N PLUM GROVE RD, STE F SE DECISION MADE: 20-DEC-10 SCHAUMBURG IL 60173 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) HEZE JUXINYUAN FOOD CO., LTD 510(k) NO: K102977(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 RM 1606 BLD 1 JIAN XIANG YUAN N209SE DECISION MADE: 20-DEC-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS COMED CO., LTD 510(k) NO: K100703(TRADITIONAL) ATTN: BRANDON CHOI PHONE NO : 714 523 1592 49 CANDLEWOOD WAY SE DECISION MADE: 21-DEC-10 BUENA PARK CA 90621 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 GAMBRO RENAL PRODUCTS, INC. 510(k) NO: K100451(TRADITIONAL) ATTN: KAE MILLER PHONE NO : 303 222 6724 14143 DENVER WEST PARKWAY SUITE 40SE DECISION MADE: 21-DEC-10 LAKEWOOD CO 80401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COULTER LIN-X LINEARITY CONTROL, MODEL A81196 BECKMAN COULTER, INC. 510(k) NO: K100790(TRADITIONAL) ATTN: LOURDES M COBA PHONE NO : 305 380 4079 11800 SW 147TH AVE. SE DECISION MADE: 21-DEC-10 MIAMI FL 33196 2500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K101715(TRADITIONAL) ATTN: RANDOLPH QUINN PHONE NO : 781 699 9505 920 WINTER STREET SE DECISION MADE: 21-DEC-10 WALTHAM MA 02451 1457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEOSOURCE ELECTRICAL GEODESICS, INC. 510(k) NO: K092844(TRADITIONAL) ATTN: PAUL HOLMAN PHONE NO : 541 687 7962 29611 SIMMONS ROAD SE DECISION MADE: 21-DEC-10 EUGENE OR 97405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARRIGEN ETEX CORP. 510(k) NO: K100883(TRADITIONAL) ATTN: CHRISTOPHER KLACZYK PHONE NO : 617 577 7270 38 SIDNEY ST. SE DECISION MADE: 21-DEC-10 CAMBRIDGE MA 02139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE I-SENS, INC. 510(k) NO: K100937(TRADITIONAL) ATTN: HYUN OH PHONE NO : 822 916 6191 465-6 WOLGYE-DONG, NOWON-GU SE DECISION MADE: 21-DEC-10 SEOUL KS 139-845 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEKSELL GAMMAPLAN ELEKTA INSTRUMENT AB 510(k) NO: K103093(TRADITIONAL) ATTN: BO NILSSON PHONE NO : 468 587 25400 KUNGSTENSGATAN 18 P.O.BOX 7593 SE DECISION MADE: 21-DEC-10 STOCKHOLM SW S-103 93 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 VERIDEX, LLC 510(k) NO: K103502(SPECIAL) ATTN: SARAH MCMANUS PHONE NO : 908 704 3920 1001 US HIGHWAY 202 NORTH SE DECISION MADE: 21-DEC-10 RARITAN NJ 08869 0606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TARGON FN SYSTEM AESCULAP IMPLANT SYSTEMS, LLC 510(k) NO: K102057(TRADITIONAL) ATTN: KATHY A RACOSKY PHONE NO : 610 984 9291 3773 CORPORATE PARKWAY SE DECISION MADE: 21-DEC-10 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS ALERE, SAN DIEGO, DBA BIOSITE INCO510(k) NO: K102700(TRADITIONAL) ATTN: EDWARD BREHM PHONE NO : 858 805 3071 9975 SUMMERS RIDGE ROAD SE DECISION MADE: 21-DEC-10 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY ASCENSION ORTHOPEDICS, INC. 510(k) NO: K102549(TRADITIONAL) ATTN: SUSAN WALTON PHONE NO : 512 836 5001 8700 CAMERON RD., STE. 100 SE DECISION MADE: 21-DEC-10 AUSTIN TX 78754 3832 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS ENCORE MEDICAL, L.P. 510(k) NO: K103223(TRADITIONAL) ATTN: ALBERT E ALONSO PHONE NO : 512 834 6235 9800 METRIC BLVD. SE DECISION MADE: 21-DEC-10 AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, "M" ADAPTER EX3180 ST JUDE MEDICAL, CRMD 510(k) NO: K101982(TRADITIONAL) ATTN: GINA CORREA PHONE NO : 408 522 6775 701 E. EVELYN AVENUE SE DECISION MADE: 21-DEC-10 SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MATRYX INTERFERENCE SCREW (5.0-6.5MM) CONMED LINVATEC 510(k) NO: K102410(TRADITIONAL) ATTN: ASHLEA BOWEN PHONE NO : 727 399 5564 11311 CONCEPT BOULEVARD SE DECISION MADE: 21-DEC-10 LARGO FL 33773 4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROVISION SE (NERVEANA) NEUROVISION MEDICAL PRODUCTS, INC.510(k) NO: K102862(TRADITIONAL) ATTN: CHRISTINE VERGELY PHONE NO : 866 815 6999 2225 SPERRY AVE, SUITE 1000 SE DECISION MADE: 21-DEC-10 VENTURA CA 93003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONIXTABLET ULTRASOUND SCANNER ULTRASONIX MEDICAL CORPORATION 510(k) NO: K102997(TRADITIONAL) ATTN: CHAS YU PHONE NO : 604 279 8550 130-4311 VIKING WAY SE DECISION MADE: 21-DEC-10 RICHMOND, BRITISH COLUMBIA CA V510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW HERAEUS KULZER, LLC 510(k) NO: K102770(TRADITIONAL) ATTN: CHERYL ZIMMERMAN PHONE NO : 574 299 5444 300 HERAEUS WAY SE DECISION MADE: 21-DEC-10 SOUTH BEND IN 46614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSOM C. DIFFICILE TOXIN A/B TEST GENZYME CORPORATION 510(k) NO: K102242(TRADITIONAL) ATTN: CAROL C RYERSON PHONE NO : 508 661 1154 31 NEW YORK AVENUE SE DECISION MADE: 21-DEC-10 FRAMINGHAM MA 01701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC MEDCOMP 510(k) NO: K102966(TRADITIONAL) ATTN: JEAN CALLOW PHONE NO : 215 256 4201 1499 DELP DR. SE DECISION MADE: 21-DEC-10 HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE MAGNATONE HEARING AID CORP. DBA PE510(k) NO: K093715(ABBREVIATED) ATTN: DON CAMPBELL PHONE NO : 407 339 2422 170 N. CYPRESS WAY SE DECISION MADE: 22-DEC-10 CASSELBERRY FL 32707 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REAVILLMED PRESSURE MONITORING SYSTEM AND PICC REAVILLMED 510(k) NO: K101189(TRADITIONAL) ATTN: MICHELE H VOVOLKA PHONE NO : 847 856 0355 888 E. BELVIDERE ROAD SUITE 212 SE DECISION MADE: 22-DEC-10 GRAYSLAKE IL 60030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE STAAR JAPAN 510(k) NO: K101782(SPECIAL) ATTN: JACK COGGAN PHONE NO : 626 303 7902 1911 WALKER AVENUE SE DECISION MADE: 22-DEC-10 MONROVIA CA 91016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES HOWMEDICA OSTEONICS CORP. 510(k) NO: K102992(TRADITIONAL) ATTN: AVITAL MERL-MARGULIES PHONE NO : 325 CORPORATE DRIVE SE DECISION MADE: 22-DEC-10 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD DIGNISHELD STOOL MANAGEMENT SYSTEM C.R. BARD, INC. 510(k) NO: K102391(TRADITIONAL) ATTN: SCOTT PEASE PHONE NO : 770 784 6774 8195 INDUSTRIAL BLVD. SE DECISION MADE: 22-DEC-10 MADISON GA 30014 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NEO-SERVO I ATOM MEDICAL CORPORATION 510(k) NO: K102710(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSTAGE DRIVE SE DECISION MADE: 22-DEC-10 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS HINSON AND HALE MEDICAL TECHNOLOGI510(k) NO: K102783(TRADITIONAL) ATTN: JEFFREY O STULL PHONE NO : 512 288 8272 7809 ADELAIDE DRIVE SE DECISION MADE: 22-DEC-10 AUSTIN TX 78739 510(k) STATEMENT DEVICE: RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH COLOPLAST A/S 510(k) NO: K103568(SPECIAL) ATTN: JANELL A COLLEY PHONE NO : 612 287 4211 1601 WEST RIVER ROAD NORTH SE DECISION MADE: 22-DEC-10 MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLYGO BREAST PUMP EVENFLO COMPANY, INC. 510(k) NO: K102600(SPECIAL) ATTN: AMY NEFF PHONE NO : 937 415 3300 225 BYERS RD. SE DECISION MADE: 22-DEC-10 MIAMISBURG OH 45342 510(k) STATEMENT DEVICE: PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE C.R. BARD INC 510(k) NO: K103109(SPECIAL) ATTN: DENNIS SALZMANN PHONE NO : 801 522 5432 605 NORTH 5600 WEST SE DECISION MADE: 22-DEC-10 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANTERIOR APPROACH HIP SURGERY INSTRUMENTS WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K102565(SPECIAL) ATTN: GREGORY NEAL PHONE NO : 901 867 5812 5677 AIRLINE RD. SE DECISION MADE: 22-DEC-10 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER COVIDIEN LLC, FORMERLY REGISTERED 510(k) NO: K102605(TRADITIONAL) ATTN: DANIEL CAMPION PHONE NO : 508 452 4135 15 HAMPSHIRE ST. SE DECISION MADE: 22-DEC-10 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULSE OXIMETER NONIN MEDICAL, INC. 510(k) NO: K102350(TRADITIONAL) ATTN: LORI M MITCHELL PHONE NO : 763 577 3093 13700 1ST AVE. NORTH SE DECISION MADE: 22-DEC-10 PLYMOUTH MN 55441 5443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMAL MASSAGE BED, MODEL 2D-GX INAREX CORPORATION 510(k) NO: K102281(SPECIAL) ATTN: EILEEN YANG PHONE NO : 82 42 4762977 MIGUN TECHNO WORLD 2 C-DONG 2 C-DOSE DECISION MADE: 22-DEC-10 YUSEONG-GU, DAEJON KS 533-1 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH VASCULAR SOLUTIONS, INC. 510(k) NO: K103405(SPECIAL) ATTN: MATT NIENSTEDT PHONE NO : 763 656 4300 6464 SYCAMORE COURT SE DECISION MADE: 22-DEC-10 MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESPRIT VENTILATOR WITH APRV OPTION, V200 VENTILATOR WITH APRV OPTION, MODELS V1000, V200 RESPIRONICS CALIFORNIA, INC. 510(k) NO: K102054(TRADITIONAL) ATTN: TAMATHA LEY PHONE NO : 760 918 1026 2271 COSMOS CT. SE DECISION MADE: 22-DEC-10 CARLSBAD CA 92011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFEPAK 12 PHYSIO-CONTROL, INC. 510(k) NO: K102972(SPECIAL) ATTN: MICHELLE ACKERMANN PHONE NO : 425 867 4744 11811 WILLOWS ROAD NORTHEAST P.O. SE DECISION MADE: 22-DEC-10 REDMOND WA 98073 9706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM TRUEVISION SYSTEMS, INCORPORATED 510(k) NO: K101861(TRADITIONAL) ATTN: BURTON TRIPATHI PHONE NO : 805 963 9709 114 EAST HALEY STREET, SUITE L SE DECISION MADE: 22-DEC-10 SANTA BARBARA CA 93101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, LIFE-TECH, INC. 510(k) NO: K102007(SPECIAL) ATTN: JEFF KASOFF PHONE NO : 281 491 6600 13235 NORTH PROMENADE BLVD. SE DECISION MADE: 22-DEC-10 STAFFORD TX 77477 510(k) STATEMENT DEVICE: AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM QUANTEL MEDICAL S.A. 510(k) NO: K102027(TRADITIONAL) ATTN: MICHAEL JOHNSON PHONE NO : 406 586 0131 601 HAGGERTY LANE SE DECISION MADE: 22-DEC-10 BOZEMAN MT 59715 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T RAPID BIOMEDICAL GMBH 510(k) NO: K102348(ABBREVIATED) ATTN: ARMIN PUREA PHONE NO : 499 365 88260 KETTELERSTR. 3-11 SE DECISION MADE: 22-DEC-10 RIMPAR, BAVARIA GM 97222 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MI VARNISH GC AMERICA INC. 510(k) NO: K102808(TRADITIONAL) ATTN: MARK HEISS PHONE NO : 708 897 4042 3737 WEST 127TH STREET SE DECISION MADE: 22-DEC-10 ALSIP IL 60803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOLIFE NASAL MASK RESPIRONICS, INC. 510(k) NO: K102502(SPECIAL) ATTN: MICHELLE BRINKER PHONE NO : 724 387 4146 365 PLUM INDUSTRIAL COURT SE DECISION MADE: 22-DEC-10 PITTSBURGH PA 15239 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESOLUTION II CLIP BOSTON SCIENTIFIC CORPORATION 510(k) NO: K102764(TRADITIONAL) ATTN: ELENA NIEVES PHONE NO : 508 683 4347 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 22-DEC-10 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PACIFIC XTREME PTCA BALLOON DILATATION CATHETER MEDTRONIC INC. 510(k) NO: K103464(SPECIAL) ATTN: HEATHER MOROSE PHONE NO : 978 739 3187 37A CHERRY HILL DRIVE SE DECISION MADE: 22-DEC-10 DANVERS MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX UNIVERS II SHOULDER PROSTHESIS ARTHREX, INC. 510(k) NO: K103466(SPECIAL) ATTN: SALLY FOUST, RAC PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 22-DEC-10 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030 CAS MEDICAL SYSTEMS, INC. 510(k) NO: K094030(TRADITIONAL) ATTN: RON JEFFREY PHONE NO : 203 488 6056 44 EAST INDUSTRIAL RD. SE DECISION MADE: 23-DEC-10 BRANFORD CT 06405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 AALTO SCIENTIFIC LTD. 510(k) NO: K100715(TRADITIONAL) ATTN: BRANDON J PEREZ PHONE NO : 760 431 7922 1959 KELLOGG AVE. SE DECISION MADE: 23-DEC-10 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRA SEAL STERILE LUBRICATING JELLY ULTRA SEAL CORPORATION 510(k) NO: K101522(TRADITIONAL) ATTN: JAMES DAVIS PHONE NO : 845 255 2490 521 MAIN STREET SE DECISION MADE: 23-DEC-10 NEW PALTZ NY 12561 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUDIT MICROCV HS-CRP LINEARITY SET AALTO SCIENTIFIC LTD. 510(k) NO: K101427(TRADITIONAL) ATTN: DESSI LYAKOV PHONE NO : 760 431 7922 1959 KELLOGG AVE. SE DECISION MADE: 23-DEC-10 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS KIMBERLY-CLARK CORP. 510(k) NO: K103406(TRADITIONAL) ATTN: DAVID M LEE PHONE NO : 770 587 7167 1400 HOLCOMB BRIDGE RD. BLDG 300, SE DECISION MADE: 23-DEC-10 ROSWELL GA 30076 2199 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NYDIAG 200 INTERACOUSTICS A/S 510(k) NO: K102364(TRADITIONAL) ATTN: ERIK NIELSEN PHONE NO : 456 371 3555 DREJERVAENGET 8 SE DECISION MADE: 23-DEC-10 ASSENS DA DK-5610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL LUNA MANUAL WHEELCHAIR P.D.G., INC. 510(k) NO: K102910(TRADITIONAL) ATTN: EDWARD A KROLL PHONE NO : 440 546 9810 5905 FAWN LANE SE DECISION MADE: 23-DEC-10 CLEVELAND OH 44141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPACT WHEELCHAIR PLATFORM DESIGN SPECIFIC FLETCHER 510(k) NO: K101723(TRADITIONAL) ATTN: RICHARD FLETCHER PHONE NO : UNIT 10 CABURN ENTERPRISE PARK THESE DECISION MADE: 23-DEC-10 RINGMER EAST SUSSEX UK BN8 5NP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM UNITED INTEGRATED SERVICES CO., LT510(k) NO: K102134(TRADITIONAL) ATTN: DAVID O CHANG PHONE NO : 886 2 29170366 PAOCHIAO ROAD 8F, # 4, ALLEY 1, LNSE DECISION MADE: 23-DEC-10 HSINTIEN CITY, TAIPEI HSIEN TW 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 ROCHE DIAGNOSTICS 510(k) NO: K103221(TRADITIONAL) ATTN: KELLY C O'MAINE ADAMS PHONE NO : 317 521 3577 9115 HAGUE ROAD P.O. BOX 50416 SE DECISION MADE: 23-DEC-10 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE CROSSTEX INTERNATIONAL, INC. 510(k) NO: K103303(TRADITIONAL) ATTN: RICHARD M ORMSBEE PHONE NO : 763 551 2689 14605 28TH AVENUE NORTH SE DECISION MADE: 23-DEC-10 MINNEAPOLIS MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K103049(SPECIAL) ATTN: LILA JOE PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 23-DEC-10 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERBEFLO 2 DISPOSABLE TUBING SYSTEM ERBE USA, INC. 510(k) NO: K103235(TRADITIONAL) ATTN: JOHN TARTAL PHONE NO : 770 955 4400 2225 NORTHWEST PKWY. SE DECISION MADE: 23-DEC-10 MARIETTA GA 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3.0T METAFLEXCOIL NEOCOIL, LLC 510(k) NO: K103342(TRADITIONAL) ATTN: BRIAN BROWN PHONE NO : 262 347 1250 N27 W23910A PAUL RD. SE DECISION MADE: 23-DEC-10 PEWAUKEE WI 53072 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: US ENDOSCOPY CYTOLOGY BRUSH UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K103437(SPECIAL) ATTN: CARROLL L MARTIN PHONE NO : 440 639 4494 5976 HEISELY RD. SE DECISION MADE: 23-DEC-10 MENTOR OH 44060 510(k) STATEMENT DEVICE: HIROLLER ELEVATING WHEELCHAIR MAX MOBILITY, LLC 510(k) NO: K102837(TRADITIONAL) ATTN: WILLIAM M RICHTER PHONE NO : 615 731 1860 5425 MOUNT VIEW PARKWAY SE DECISION MADE: 23-DEC-10 ANTIOCH TN 37013 510(k) STATEMENT DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES HEBEI HONGTAI PLASTIC PRODUCTS CO.510(k) NO: K102817(TRADITIONAL) ATTN: RICHARD LU PHONE NO : 861 064 796097 ROOM 3-402, NO 71 MAJIAPU YANGQIAOSE DECISION MADE: 23-DEC-10 BEIJING CH 100068 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES HEBEI HONGTAI PLASTIC PRODUCTS CO.510(k) NO: K102819(TRADITIONAL) ATTN: RICHARD LU PHONE NO : 861 064 796097 ROOM 3-402, NO 71 MAJIAPU YANGQIAOSE DECISION MADE: 23-DEC-10 BEIJING CH 100068 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEFOGGING AND CLEANING SOLUTION- FLO-X MINIMALLY INVASIVE DEVICES LLC 510(k) NO: K102452(TRADITIONAL) ATTN: MARK L FRIEDMAN, PH.D PHONE NO : 352 275 7929 6329 SW 81ST ROAD SE DECISION MADE: 23-DEC-10 LAKE BUTLER FL 32054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INCLUSIVE MINI IMPLANT PRISMATIK DENTALCRAFT, INC. 510(k) NO: K100932(ABBREVIATED) ATTN: KEITH ALLRED PHONE NO : 949 399 1732 4141 MACARTHUR BLVD SE DECISION MADE: 27-DEC-10 NEWPORT BEACH CA 92660 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT SAINATH INTELLECTUAL PROPERTIES, L510(k) NO: K102572(TRADITIONAL) ATTN: CHRISTOPHER PARADIES, PH.D.PHONE NO : 813 222 1190 501 E KENNEDY BLVD. SUITE 1700 SE DECISION MADE: 27-DEC-10 TAMPA FL 33602 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOSEVIEW 3D STANDARD IMAGING, INC. 510(k) NO: K103193(TRADITIONAL) ATTN: RAYMOND T RIDDLE PHONE NO : 608 831 0025 3120 DEMING WAY SE DECISION MADE: 27-DEC-10 MIDDLETON WI 53562 1461 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND ELLEX, INC. 510(k) NO: K103608(SPECIAL) ATTN: JONATHAN STRAWN PHONE NO : 916 363 0774 9940 BUSINESS PARK DR. SUITE 165 SE DECISION MADE: 27-DEC-10 SACRAMENTO CA 95827 510(k) STATEMENT DEVICE: MEDISTIM VERIQC SYSTEM MEDI-STIM ASA 510(k) NO: K102595(TRADITIONAL) ATTN: CONSTANCE G BUNDY PHONE NO : 763 574 1976 435 RICE CREEK TERRACE NE SE DECISION MADE: 27-DEC-10 FRIDLEY MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK) C.R. BARD, INC. 510(k) NO: K103359(SPECIAL) ATTN: CINDY MOSS PHONE NO : 480 379 2836 1415 W 3RD STREET SE DECISION MADE: 27-DEC-10 TEMPE AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL DIAGNOSTIC X-RAY SYSTEM DRGEM CORPORATION 510(k) NO: K102408(TRADITIONAL) ATTN: CHARLIE MACK PHONE NO : 541 376 5063 77325 JOYCE WAY SE DECISION MADE: 27-DEC-10 EHCO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFEBRIDGE LIFEBRIDGE MEDIZINTECHNIK AG 510(k) NO: K103357(SPECIAL) ATTN: KATHLEEN JOHNSON PHONE NO : 610 527 0585 1282 ROUND HILL RD. SE DECISION MADE: 27-DEC-10 BRYN MAWR PA 19010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOPHIL BETA-TCP CYTOPHIL INC 510(k) NO: K102937(TRADITIONAL) ATTN: VICTOR M BOWERS PHONE NO : 262 642 2765 2485 CORPORATE CIRCLE SUITE 2 SE DECISION MADE: 27-DEC-10 EAST TROY WI 53120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DC-7 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K103583(TRADITIONAL) ATTN: ZHAI PEI PHONE NO : 867 558 1885604 MINDRAY BLDG. KEJI 12TH RD S. HI-TSE DECISION MADE: 27-DEC-10 SHENZHEN, GUANGDONG CH 518057 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS PRISMATIK DENTALCRAFT, INC. 510(k) NO: K100993(ABBREVIATED) ATTN: KEITH ALLRED PHONE NO : 949 440 2683 4141 MACARTHUR BLVD. SE DECISION MADE: 28-DEC-10 NEWPORT BEACH CA 92660 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIRAGE FX RESMED LTD. 510(k) NO: K102746(TRADITIONAL) ATTN: DAVID D'CRUZ PHONE NO : 858 836 5984 9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 28-DEC-10 SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACL TIGHTROPE DOUBLE BUNDLE ARTHREX, INC. 510(k) NO: K101837(TRADITIONAL) ATTN: GEENA AUGUSTINE PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 28-DEC-10 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K102210(TRADITIONAL) ATTN: BERNICE LIN PHONE NO : 408 732 3856 670 ALMANOR AVENUE SE DECISION MADE: 28-DEC-10 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAPPHIRE ST PORTABLE DIODE LASER DEN-MAT HOLDINGS, LLC 510(k) NO: K103667(TRADITIONAL) ATTN: ALAN B MATTHEWS PHONE NO : 805 922 8491 2727 SKYWAY DR. SE DECISION MADE: 29-DEC-10 SANTA MARIA CA 93455 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INCU I ATOM MEDICAL CORPORATION 510(k) NO: K102279(TRADITIONAL) ATTN: TSUYOSHI SUGINO PHONE NO : 813 381 53632 3-18-15 HONGO SE DECISION MADE: 29-DEC-10 BUNKYO-KU, TOKYO JA 113-0033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZENIUS SPINAL SYSTEM MEDYSSEY CO., LTD. 510(k) NO: K103272(SPECIAL) ATTN: PATRICK MOORE PHONE NO : 801 266 4811 6170 SOUTH 380 WEST SUITE 200 SE DECISION MADE: 29-DEC-10 MURRAY UT 84107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFRARED EAR THERMOMETER RADIANT INNOVATION, INC. 510(k) NO: K103097(SPECIAL) ATTN: JAMES HUANG PHONE NO : 886 361 11666 1F,NO. 3,INDUSTRIAL E. 9TH RD SCIESE DECISION MADE: 29-DEC-10 HSINCHU TW 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANTATA MICROCATHETER COOK, INC. 510(k) NO: K101450(SPECIAL) ATTN: MIRONDA CARPENTER PHONE NO : 812 339 2235 750 DANIELS WAY P.O. BOX 489 SE DECISION MADE: 30-DEC-10 BLOOMINGTON IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER ABBOTT VASCULAR-CARDIAC THERAPIES 510(k) NO: K103153(TRADITIONAL) ATTN: SUZANNE REDMAN PHONE NO : 951 914 3243 26531 YNEZ RD. MAILING P.O. BOX 90SE DECISION MADE: 30-DEC-10 TEMECULA CA 92589 9018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AED RESECTOSCOPE NATIONAL ADVANCED ENDOSCOPY DEVICE510(k) NO: K102663(TRADITIONAL) ATTN: GAYLE BUTLER PHONE NO : 818 227 2720 22134 SHERMAN WAY SE DECISION MADE: 30-DEC-10 CANOGA PARK CA 91303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G-CINCH SUTURE GRASPER USGI MEDICAL 510(k) NO: K102931(TRADITIONAL) ATTN: MARY LOU MOONEY PHONE NO : 949 369 3890 1140 CALLE CORDILLERA SE DECISION MADE: 30-DEC-10 SAN CLEMENTE CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IRRIGATION SYSTEM UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K103239(TRADITIONAL) ATTN: CARROLL L MARTIN PHONE NO : 440 639 4494 5976 HEISELY RD. SE DECISION MADE: 30-DEC-10 MENTOR OH 44060 510(k) STATEMENT DEVICE: C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG AAT ALBER ANTRIEBSTECHNIK GMBH 510(k) NO: K103122(TRADITIONAL) ATTN: STEFANIE D BANKSTON PHONE NO : 409 229 0022 2611 SHARK CIRCLE SE DECISION MADE: 30-DEC-10 TEXAS CITY TX 77591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BNX FINE NEEDLE ASPIRATION SYSTEM BOSTON ENDOSCOPIC ENGINEERING 510(k) NO: K103668(TRADITIONAL) ATTN: ANNETTE M FAGNANT PHONE NO : 401 392 0287 53 KENNEDY ROAD SE DECISION MADE: 30-DEC-10 FOSTER RI 02825 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE SMART MEDICAL SYSTEMS, LTD. 510(k) NO: K102616(TRADITIONAL) ATTN: ADVA YOSELZON PHONE NO : 972 9 7444478 10 HAYETSIRA STREET SE DECISION MADE: 30-DEC-10 RAANANA IS 43663 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXIOM FASCIAL CLOSURE SYSTEM AXIOM TECHNOLOGY PARTNERS, LLC 510(k) NO: K103412(TRADITIONAL) ATTN: RICHARD RUSH PHONE NO : 650 595 1104 2939 ALHAMBRA DRIVE SE DECISION MADE: 30-DEC-10 BELMONT CA 94002 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 294 TOTAL WITH SUMMARIES 271 TOTAL WITH STATEMENTS 23
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