April 2011 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD April 2011 DEVICE: VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM C.R. BARD, INC. 510(k) NO: K110820(SPECIAL) ATTN: KETI SINO PHONE NO : 401 825 8575 100 CROSSINGS BOULEVARD SE DECISION MADE: 01-APR-11 WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSEOTITE II MODEL XIFOSSXXX BIOMET 3I, INC. 510(k) NO: K100724(TRADITIONAL) ATTN: JOSE E CABRERA PHONE NO : 561 776 6840 4555 RIVERSIDE DR. SE DECISION MADE: 01-APR-11 PALM BEACH GARDENS FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01 CEDARS-SINAI MEDICAL CENTER 510(k) NO: K100714(TRADITIONAL) ATTN: DAVID R DILLS PHONE NO : 904 519 8040 8787 SOUTHSIDE BLVD., #719 SE DECISION MADE: 01-APR-11 JACKSONVILLE FL 32256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPRESSYN BAND DALLEN MEDICAL 510(k) NO: K101484(TRADITIONAL) ATTN: AL MEMMOLO PHONE NO : 949 218 0030 1046 CALLE RECODO SUITE G SE DECISION MADE: 01-APR-11 SAN CLEMENTE CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM ACCLARENT, INC. 510(k) NO: K103595(TRADITIONAL) ATTN: GURVINDER SINGH NANDA PHONE NO : 650 687 5414 1525-B O'BRIEN DR. SE DECISION MADE: 01-APR-11 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD CONSENSUS ORTHOPEDICS, INC. 510(k) NO: K110542(TRADITIONAL) ATTN: MATTHEW HULL PHONE NO : 916 355 7100 1115 WINDFIELD WAY, SUITE 100 SE DECISION MADE: 01-APR-11 EL DORADO HILLS CA 95762 9623 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPEDIUM SYSTEM, VIPER SYSTEM DEPUY SPINE, INC. 510(k) NO: K110216(SPECIAL) ATTN: EUGENE BANG PHONE NO : 508 977 3966 325 PARAMOUNT DR. SE DECISION MADE: 01-APR-11 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K110522(SPECIAL) ATTN: NICHOLAS TABRIZI PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 01-APR-11 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL GE MEDICAL SYSTEMS, LLC 510(k) NO: K110610(SPECIAL) ATTN: MICHELLE SCHEIDT PHONE NO : 262 521 6102 3200 N. GRANDVIEW BLVD. SE DECISION MADE: 01-APR-11 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYLATOPICPLUS CREAM PRECISION DERMATOLOGY INCORPORATED510(k) NO: K110727(SPECIAL) ATTN: RONALD M GURGE PHONE NO : 401 762 2000 900 HIGHLAND CORPORATE DRIVE SE DECISION MADE: 01-APR-11 CUMBERLAND RI 02864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS ABBOT LABORATORIES 510(k) NO: K102699(TRADITIONAL) ATTN: JUDITH WALLACH PHONE NO : 847 937 1132 100 ABBOTT PARK RD. DEPT. 9V6 AP6CSE DECISION MADE: 01-APR-11 ABBOTT PARK IL 60064 6092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES... EXACTECH, INC. 510(k) NO: K110708(SPECIAL) ATTN: LINDY KNISELY PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 01-APR-11 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALYTE Y-MESH GRAFT C.R. BARD, INC. 510(k) NO: K101722(TRADITIONAL) ATTN: SCOTT ROBIRDS PHONE NO : 770 784 6722 8195 INDUSTRIAL BLVD. SE DECISION MADE: 01-APR-11 COVINGTON GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERRAD SEALSURE CHEMICAL INDICATOR TAPE ADVANCED STERILIZATION PRODUCTS 510(k) NO: K103219(TRADITIONAL) ATTN: NANCY CHU PHONE NO : 949 453 6435 33 TECHNOLOGY DR. SE DECISION MADE: 01-APR-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERRAD CHEMICAL INDICATOR STRIP ADVANCED STERILIZATION PRODUCTS 510(k) NO: K103218(TRADITIONAL) ATTN: NANCY CHU PHONE NO : 949 453 6435 33 TECHNOLOGY DR. SE DECISION MADE: 01-APR-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TORFLEX TRANSSEPTAL GUIDING SHEATH BAYLIS MEDICAL CO., INC. 510(k) NO: K102948(TRADITIONAL) ATTN: MEGHAL KHAKHAR PHONE NO : 905 602 4875 2645 MATHESON BLVD. E SE DECISION MADE: 01-APR-11 MISSISSAUGA, ONTARIO CA L4W 5S4510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE ARTAS SYSTEM FROM RESTORATION ROBOTICS RESTORATION ROBOTICS, INC 510(k) NO: K103428(TRADITIONAL) ATTN: KIT CARIQUITAN PHONE NO : 408 400 0856 155-A MOFFETT PARK DRIVE SUITE 210SE DECISION MADE: 04-APR-11 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT MEDICA CORP. 510(k) NO: K101088(TRADITIONAL) ATTN: PHOTIOS MAKRIS PHONE NO : 781 275 4892 5 OAK PARK DRIVE SE DECISION MADE: 04-APR-11 BEDFORD MA 01730 510(k) STATEMENT DEVICE: NITRILE POWDER FREE PATIENT EXAMINATION GLOVES TANGSHAN BAOJIE GLOVE CO., LTD 510(k) NO: K110185(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606 BLDG1.JIANXIANG YUAN NO.SE DECISION MADE: 04-APR-11 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL FOREHEAD THERMOMETER K-JUMP HEALTH CO., LTD. 510(k) NO: K103617(SPECIAL) ATTN: JASON CHENG PHONE NO : 886 222 991378 NO. 56, WU KUNG 5TH RD., WU KU INDSE DECISION MADE: 04-APR-11 TAIPEI HSIEN TW 248 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED HD GUIDE CATHETER CONCENTRIC MEDICAL, INC. 510(k) NO: K110483(SPECIAL) ATTN: KIRSTEN VALLEY PHONE NO : 650 810 1707 301 E. EVELYN AVE. SE DECISION MADE: 04-APR-11 MOUNTAIN VIEW CA 94041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAULT ALIF SYSTEM SPINAL USA 510(k) NO: K103369(TRADITIONAL) ATTN: LINDA POLK PHONE NO : 601 420 4244 2050 EXECUTIVE DR. SE DECISION MADE: 04-APR-11 PEARL MS 39208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RT600 RESTORATIVE THERAPIES INC. 510(k) NO: K103366(TRADITIONAL) ATTN: SCOTT SIMCOX PHONE NO : 800 609 9166 907 SOUTH LAKEWOOD AVE. SE DECISION MADE: 04-APR-11 BALTIMORE MD 21224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KNEEALIGN SYSTEM ORTHALIGN, INC 510(k) NO: K103829(TRADITIONAL) ATTN: AMY WALTERS PHONE NO : 949 923 9400 338 VISTA MADERA SE DECISION MADE: 04-APR-11 NEWPORT BEACH CA 92660 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM SOUND SURGICAL TECHNOLOGIES LLC. 510(k) NO: K110255(TRADITIONAL) ATTN: STEPHEN C SMITH PHONE NO : 720 240 2970 357 S. MCCASLIN BLVD. #100 SE DECISION MADE: 04-APR-11 LOUISVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CARDIOHELP SYSTEM MAQUET CARDIOPULMONARY AG 510(k) NO: K102726(TRADITIONAL) ATTN: ROLAND JEHLE PHONE NO : 004 974 78921373 HECHINGER STRASSE 38 SE DECISION MADE: 04-APR-11 HIRRLINGEN GM 72145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRAINLAB KNEE BRAINLAB AG 510(k) NO: K102990(SPECIAL) ATTN: ALEXANDER SCHWIERSCH PHONE NO : 498 999 15680 KAPELLENSTRASSE 12 SE DECISION MADE: 04-APR-11 FELDKIRCHEN GM 85622 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPRESSION COMPOUND SPOFADENTAL 510(k) NO: K110378(TRADITIONAL) ATTN: WENDY GARMAN PHONE NO : 714 516 7602 1717 WEST COLLINS AVENUE SE DECISION MADE: 05-APR-11 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM CHURCH & DWIGHT CO., INC. 510(k) NO: K100767(TRADITIONAL) ATTN: JOSEPH CICCONE PHONE NO : 609 497 7251 469 NORTH HARRISON STREET SE DECISION MADE: 05-APR-11 PRINCETON NJ 08543 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1 SALIENT SURGICAL TECHNOLOGIES 510(k) NO: K101057(TRADITIONAL) ATTN: KERRI MORTON PHONE NO : 603 742 1515 180 INTERNATIONAL DRIVE SE DECISION MADE: 05-APR-11 PORTSMOUTH NH 03801 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CUTERA GENESISPLUS LASER SYSTEM CUTERA, INC. 510(k) NO: K103626(TRADITIONAL) ATTN: CONNIE HOY PHONE NO : 415 657 5592 3240 BAYSHORE BLVD SE DECISION MADE: 05-APR-11 BRISBANE CA 94005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM TORNIER, INC. 510(k) NO: K103262(TRADITIONAL) ATTN: HOWARD L SCHRAYER PHONE NO : 609 924 9510 100 CUMMINGS CENTER SUITE 444C SE DECISION MADE: 05-APR-11 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS RESPIRONICS CALIFORNIA, INC. 510(k) NO: K102985(TRADITIONAL) ATTN: TAMATHA LEY PHONE NO : 760 918 1026 2271 COSMOS CT. SE DECISION MADE: 05-APR-11 CARLSBAD CA 92011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRITY SPINAL CARE SYSTEM INTEGRA LIFE SCIENCES 510(k) NO: K103248(TRADITIONAL) ATTN: JAMES J GIBSON PHONE NO : 702 997 7190 5795 SOUTH SANDHILL ROAD SUITE F, SE DECISION MADE: 05-APR-11 LAS VEGAS NV 89120 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: RT200 RESTORATIVE THERAPIES INC. 510(k) NO: K103370(TRADITIONAL) ATTN: ANDREW BARRISKILL PHONE NO : 800 609 9166 907 SOUTH LAKEWOOD AVE. SE DECISION MADE: 05-APR-11 BALTIMORE MD 21224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOSIL LA POSITIVE CONTROL INSTRUMENTATION LABORATORY CO. 510(k) NO: K102552(TRADITIONAL) ATTN: CAROL MARBLE PHONE NO : 781 861 4467 180 HARTWELL ROAD SE DECISION MADE: 05-APR-11 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESTELITE COLOR TOKUYAMA DENTAL CORPORATION 510(k) NO: K110178(TRADITIONAL) ATTN: KEITH A BARRITT PHONE NO : 202 783 5070 1425 K STREET, N.W. SUITE 1100 SE DECISION MADE: 05-APR-11 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHARPS CONTAINER NOBLE MARKETING 510(k) NO: K110262(TRADITIONAL) ATTN: ALLISON SCOTT PHONE NO : 317 569 9500 11460 N. MERIDIAN ST. SUITE 150 SE DECISION MADE: 05-APR-11 CARMEL IN 46032 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: REVERSE MEDICAL REFLEX GUIDE CATHETER REVERSE MEDICAL CORPORATION 510(k) NO: K110055(TRADITIONAL) ATTN: AMY ESKINA PHONE NO : 949 215 0660 13900 ALTON PARKWAY SUITE 123 SE DECISION MADE: 05-APR-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TEMPOROMANIBULAR COIL 15 ESAOTE S.P.A. 510(k) NO: K110373(TRADITIONAL) ATTN: DONATELLA RAGGHIANTI PHONE NO : 011 390 106547259 VIA SIFFREDI 58 SE DECISION MADE: 06-APR-11 GENOVA IT 16153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR CARD GUARD SCIENTIFIC SURVIVAL LTD510(k) NO: K110499(SPECIAL) ATTN: CLAY ANSELMO PHONE NO : 303 223 4303 555 ZANG ST SUITE 100 SE DECISION MADE: 06-APR-11 LAKEWOOD CO 80228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES US MEDICAL INNOVATIONS LLC 510(k) NO: K100669(TRADITIONAL) ATTN: KRISTA OAKES PHONE NO : 512 327 9997 1705 S. CAPITAL OF TEXAS HWY SUITESE DECISION MADE: 06-APR-11 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K100375(TRADITIONAL) ATTN: PAMELA JURGA PHONE NO : 302 631 8891 PO BOX 6101 M/S 514 SE DECISION MADE: 06-APR-11 NEWARK DE 19714 6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST ALCOPRO, INC. 510(k) NO: K102225(TRADITIONAL) ATTN: PERRY RUCKER PHONE NO : 310 415 7093 1560 E. EDINGER AVENUE, SUITE B SE DECISION MADE: 06-APR-11 SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HAIRMAX LASERCOMB LEXINGTON INTERNATIONAL, LLC 510(k) NO: K103368(TRADITIONAL) ATTN: CASPER E ULDRIKS ESQ. PHONE NO : 202 518 6385 1400 SIXTEENTH STREET, NW SUITE 40SE DECISION MADE: 06-APR-11 WASHINGTON DC 20036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO MBF SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K110494(SPECIAL) ATTN: ELAINE CHANG PHONE NO : 847 304 7516 2501 NORTH BARRINGTON RD. SE DECISION MADE: 06-APR-11 HOFFMAN ESTATES IL 60192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISA CO2, ISA AX+, ISA OR+ PHASEIN AB 510(k) NO: K103604(TRADITIONAL) ATTN: DAVID WEISSBURG PHONE NO : 608 770 0223 4213 WINNEQUAH DR. SE DECISION MADE: 06-APR-11 MADISON WI 53716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRONTOSAN WOUND IRRIGATION SOLUTION B. BRAUN MEDICAL, INC. 510(k) NO: K110744(TRADITIONAL) ATTN: NANCY SKOCYPEC PHONE NO : 610 596 2796 901 MARCON BLVD. SE DECISION MADE: 06-APR-11 ALLENTOWN PA 18109 9341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIPLE BIOPSY SYSTEM UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K103326(TRADITIONAL) ATTN: CARROLL L MARTIN PHONE NO : 440 639 4494 5976 HEISELY RD. SE DECISION MADE: 06-APR-11 MENTOR OH 44060 510(k) STATEMENT DEVICE: NEWTOM 5G / NEWTOM 5G VERSION FP QR S.R.L. 510(k) NO: K110260(SPECIAL) ATTN: LORENZO BORTOLOTTI PHONE NO : 390 458 202727 VIA SILVESTRINI 20 SE DECISION MADE: 06-APR-11 VERONA, VR IT 37135 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESUSCI FLOW; RESUSCI FLOW 104 ATOM MEDICAL CORPORATION 510(k) NO: K102542(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSTAGE DRIVE SE DECISION MADE: 06-APR-11 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VELA XL STARMEDTEC GMBH 510(k) NO: K103654(TRADITIONAL) ATTN: GREGOR WEIDEMANN PHONE NO : 498 151 268610 KREUZSTRASSE 22 SE DECISION MADE: 06-APR-11 STARNBERG GM 82319 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROLIFE DIGITAL UNDERARM THERMOMETER MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K103680(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 706 7456 55 NORTHERN BOULEVARD SUITE 200 SE DECISION MADE: 06-APR-11 GREAT NECK NY 10021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE BLLOD COLLECTION NEEDLE WEIHAI HONGYU MEDICAL DEVICES CO.,510(k) NO: K103587(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 164 264467 P.O. BOX 237-023 SE DECISION MADE: 06-APR-11 SHANGHAI CH 264200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K110169(TRADITIONAL) ATTN: KATHLEEN ANN DRAY-LYONS PHONE NO : 781 826 4551 500 GBC DRIVE PO BOX 6101 SE DECISION MADE: 07-APR-11 NEWARK DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCULIF CAGE COALIGN INNOVATIONS, INC. 510(k) NO: K110270(SPECIAL) ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800 1331 H STREET NW 12TH FLOOR SE DECISION MADE: 07-APR-11 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPERT C. DIFFICLE/EPI ASSAY CEPHEID 510(k) NO: K110203(TRADITIONAL) ATTN: RUSSEL K ENNS PHONE NO : 408 400 8230 904 CARIBBEAN DRIVE SE DECISION MADE: 07-APR-11 SUNNYVALE CA 94089 1189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOUNTAINEER OCT SPINAL SYSTEM DEPUY SPINE, INC. 510(k) NO: K110353(SPECIAL) ATTN: LUKE BULINO PHONE NO : 508 828 3267 325 PARAMOUNT DR. SE DECISION MADE: 07-APR-11 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XVAC SORIN GROUP ITALIA S.R.L. 510(k) NO: K110782(TRADITIONAL) ATTN: BARRY SALL PHONE NO : 781 434 4742 195 WEST STREET SE DECISION MADE: 07-APR-11 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNAPSE 3D LIVER ANALYSIS FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K110186(TRADITIONAL) ATTN: KIMERLY A SHARP PHONE NO : 203 602 3665 419 WEST AVE. SE DECISION MADE: 07-APR-11 STAMFORD CT 06902 6300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMS AIR-FLOW MASTER PIEZON EMS ELECTRO MEDICAL SYSTEMS SA 510(k) NO: K110173(TRADITIONAL) ATTN: CYNTHIA J M. NOLTE, PH.D, RAPHONE NO : 919 859 4207 49 PLAIN ST. SE DECISION MADE: 07-APR-11 NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMBITRANS MONITORING SETS AND ACCESSORIES B. BRAUN MELSUNGEN AG 510(k) NO: K102033(ABBREVIATED) ATTN: LISA GIAQUINTO PHONE NO : 610 596 2354 901 MARCON BLVD SE DECISION MADE: 07-APR-11 ALLENTOWN PA 18109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4D SONO-SCAN 1.0 TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K110595(TRADITIONAL) ATTN: INGE SCHEIDT PHONE NO : 498 932 175515 EDISONSTRASSE 6 SE DECISION MADE: 07-APR-11 UNTERSCHLEISSHEIM GM D-85716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR IMPACT INSTRUMENTATION, INC. 510(k) NO: K103318(TRADITIONAL) ATTN: SUSAN MCNEVIN PHONE NO : 973 882 1212 27 FAIRFIELD PL. P.O. BOX 508 SE DECISION MADE: 07-APR-11 WEST CALDWELL NJ 07006 0508 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UTA AND UHA UTA 510(k) NO: K102467(TRADITIONAL) ATTN: ANGELA BLACKWELL PHONE NO : 704 450 9934 3318 SUCCESFUL WAY SE DECISION MADE: 07-APR-11 DAYTON OH 45414 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET RANDOX LABORATORIES, LTD. 510(k) NO: K092269(TRADITIONAL) ATTN: P ARMSTRONG PHONE NO : 440 289 4422413 55 DIAMOND RD. SE DECISION MADE: 08-APR-11 CRUMLIN, COUNTY ANTRIM UK BT29 510(k) STATEMENT DEVICE: INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000 INTUITIVE SURGICAL, INC. 510(k) NO: K101581(TRADITIONAL) ATTN: BRANDON HANSEN PHONE NO : 408 523 2100 1266 KIFER ROAD SE DECISION MADE: 08-APR-11 SUNNYVALE CA 94086 5206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRELUDE III TONGUE SUSPENSION SYSTEM SIESTA MEDICAL, INC. 510(k) NO: K110127(SPECIAL) ATTN: MICHAEL KOLBER PHONE NO : 408 505 6626 101 CHURCH STREET SUITE 3 SE DECISION MADE: 08-APR-11 LOS GATOS CA 95030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AGILIS ES STEERABLE INTRODUCER ST. JUDE MEDICAL 510(k) NO: K103083(TRADITIONAL) ATTN: LAURA MOEN-FTACEK PHONE NO : 651 756 2957 14901 DEVEAU PLACE SE DECISION MADE: 08-APR-11 MINNETONKA MN 55345 2126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAIRED HYDROGEL ELECTRODE NEUROVISION MEDICAL PRODUCTS, INC.510(k) NO: K110138(SPECIAL) ATTN: CHRISTINE VERGELY PHONE NO : 805 866 6999 2225 SPERRY AVE, SUITE 1000 SE DECISION MADE: 08-APR-11 VENTURA CA 93003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUITY WHISPER VIEW GUIDE WIRES BOSTON SCIENTIFIC CORP. 510(k) NO: K110479(SPECIAL) ATTN: KIRSTIN JOHNSTON PHONE NO : 651 582 5871 4100 HAMLINE AVE NORTH MS 9-330 SE DECISION MADE: 08-APR-11 ST. PAUL MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET ETHICON ENDO-SURGERY, LLC 510(k) NO: K103672(TRADITIONAL) ATTN: DENNIS HAHN PHONE NO : 513 337 3134 4545 CREEK ROAD SE DECISION MADE: 08-APR-11 CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTABLE X-RAY SYSTEM DIGIMED CORPORATION 510(k) NO: K103600(TRADITIONAL) ATTN: KIM ANTOL PHONE NO : 847 419 0669 1607 N. BARCLAY AVE. SE DECISION MADE: 08-APR-11 BUFFALO GROVE IL 60089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP THERAPEUTICS 101, INC (DBA PRESSUR510(k) NO: K110563(TRADITIONAL) ATTN: JULIE POWELL PHONE NO : 269 720 1329 611 WEST 5TH STREET THIRD FLOOR SE DECISION MADE: 08-APR-11 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTIMATE VIT ENHAMCER (UVE) MEDICAL INSTRUMENT DEVELOPMENT LAB510(k) NO: K102222(TRADITIONAL) ATTN: LINDA UPTON PHONE NO : 510 357 3952 557 MC CORMICK STREET SE DECISION MADE: 08-APR-11 SAN LEANDRO CA 94577 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K110667(TRADITIONAL) ATTN: INGE SCHEIDT PHONE NO : 498 932 175515 EDISONSTRASSE 6 SE DECISION MADE: 08-APR-11 UNTERSCHLEISSHEIM GM D-85716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACAM 5 AUDIOMETER SYSTEM ACOUSTICON GMBH 510(k) NO: K103298(TRADITIONAL) ATTN: MAUREEN GARNER PHONE NO : 732 779 7422 1983 HAZELWOOD ROAD SE DECISION MADE: 08-APR-11 TOMS RIVER NJ 08754 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY MICROGENICS CORP. 510(k) NO: K101742(TRADITIONAL) ATTN: LISA CHARTER PHONE NO : 510 979 5142 46360 FREMONT BLVD SE DECISION MADE: 08-APR-11 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY MICROGENICS CORP. 510(k) NO: K101744(TRADITIONAL) ATTN: LISA CHARTER PHONE NO : 510 979 5142 46360 FREMONT BLVD SE DECISION MADE: 08-APR-11 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY MICROGENICS CORP. 510(k) NO: K101745(TRADITIONAL) ATTN: LISA CHARTER PHONE NO : 510 979 5142 46360 FREMONT BLVD SE DECISION MADE: 08-APR-11 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY MICROGENICS CORP. 510(k) NO: K101746(TRADITIONAL) ATTN: LISA CHARTER PHONE NO : 510 979 5142 46360 FREMONT BLVD SE DECISION MADE: 08-APR-11 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XEROS DRY MOUTH PUMP LORIN TECHNOLOGIES CORPORATION 510(k) NO: K110116(TRADITIONAL) ATTN: AL TOMAN PHONE NO : 919 341 4128 436 WOODLAND DR SE DECISION MADE: 08-APR-11 SWANSBORO NC 28584 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18 ESAOTE S.P.A. 510(k) NO: K110802(SPECIAL) ATTN: ALLISON SCOTT PHONE NO : 317 569 9500 11460 N MERIDIAN ST SUITE 150 SE DECISION MADE: 08-APR-11 CARMEL IN 46032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NICOLET WIRELESS EEG CAREFUSION 209, INC. 510(k) NO: K103140(TRADITIONAL) ATTN: ROBERT BURDGE PHONE NO : 608 829 8655 1850 Deming Way SE DECISION MADE: 08-APR-11 Middleton WI 53562 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HYDROFIX VASO SHIELD MIMEDX GROUP, INC 510(k) NO: K101805(TRADITIONAL) ATTN: SALLY THORSEN PHONE NO : 678 384 6720 811 LIVINGSTON COURT SE SUITE B SE DECISION MADE: 08-APR-11 MARIETTA GA 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS MICROGENICS CORP. 510(k) NO: K101752(TRADITIONAL) ATTN: LISA CHARTER PHONE NO : 510 979 5142 46360 FREMONT BLVD SE DECISION MADE: 08-APR-11 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY MICROGENICS CORP. 510(k) NO: K101753(TRADITIONAL) ATTN: LISA CHARTER PHONE NO : 510 979 5142 46360 FREMONT BLVD SE DECISION MADE: 08-APR-11 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY MICROGENICS CORP. 510(k) NO: K101754(TRADITIONAL) ATTN: LISA CHARTER PHONE NO : 510 979 5142 46360 FREMONT BLVD SE DECISION MADE: 08-APR-11 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAKE 1 ADVANCED RIGID TRAY KERR CORPORATION 510(k) NO: K110092(TRADITIONAL) ATTN: WENDY GARMAN PHONE NO : 714 516 7602 1717 WEST COLLINS AVE. SE DECISION MADE: 08-APR-11 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UF-760AG FUKUDA DENSHI CO., LTD. 510(k) NO: K110920(TRADITIONAL) ATTN: LORAN VAN NOY PHONE NO : 425 881 7737 17725 N.E. 65TH STREET BLDG C SE DECISION MADE: 08-APR-11 REDMOND WA 98052 4911 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AMBIT TUNNELER SUMMIT MEDICAL PRODUCTS, INC 510(k) NO: K110814(ABBREVIATED) ATTN: MARKO V AMEN PHONE NO : 801 214 3464 2480 SOUTH MAIN STREET #212 SE DECISION MADE: 08-APR-11 SALT LAKE CITY UT 84118 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: APEX ER. YAG / IPL SYSTEM SANDSTONE MEDICAL TECHNOLOGIES LLC510(k) NO: K110304(TRADITIONAL) ATTN: MARK ROHRER PHONE NO : 205 290 8251 105 CITATION COURT SE DECISION MADE: 08-APR-11 BIRMINGHAM AL 35209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCENARIA WHOLE-BODY X-RAY CT SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K101888(TRADITIONAL) ATTN: DOUG THISTLETHWAITE PHONE NO : 330 425 1313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 08-APR-11 TWINSBURG OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRICURE BIPOLAR SYSTEM ATRICURE, INC. 510(k) NO: K110117(TRADITIONAL) ATTN: JAMES LUCKY, RAC PHONE NO : 513 755 5754 6217 CENTER PARK DRIVE SE DECISION MADE: 08-APR-11 WEST CHESTER OH 45069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT ASTRA TECH, INC. 510(k) NO: K103759(TRADITIONAL) ATTN: BETSY A BROWN PHONE NO : 847 560 4406 8944 TAMAROA TERR. SE DECISION MADE: 08-APR-11 SKOKIE IL 60076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEWPHEW ULTRABRAID II SUTURE SMITH & NEWPHEW, INC 510(k) NO: K101377(TRADITIONAL) ATTN: CHRISTINA FLORES PHONE NO : 508 261 3705 150 MINUTEMAND ROAD SE DECISION MADE: 08-APR-11 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENOVO TEDDY GEL INFANT HEEL WARMER DENOVO PRODUCTS LLC 510(k) NO: K103549(TRADITIONAL) ATTN: DALE WALTERS PHONE NO : 239 245 7030 17051 Alico Commerce Court Unit 3 SE DECISION MADE: 08-APR-11 Fort Myers FL 33967 510(k) STATEMENT DEVICE: LP CAGE MEDYSSEY CO., LTD. 510(k) NO: K110067(TRADITIONAL) ATTN: RICH JANSEN PHONE NO : 612 281 5505 13540 GUILD AVE SE DECISION MADE: 08-APR-11 APPLE VALLEY MN 55124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATAMA SYSTEM MONTERIS MEDICAL, INC. 510(k) NO: K110411(TRADITIONAL) ATTN: JEFF WILSON PHONE NO : 204 272 2220 100 - 78 Innovation Drive SE DECISION MADE: 08-APR-11 Winnipeg CA R3T 6C2 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER VASCULAR SOLUTIONS, INC. 510(k) NO: K102212(TRADITIONAL) ATTN: LISA GALLATIN PHONE NO : 763 656 4399 6464 SYCAMORE COURT SE DECISION MADE: 08-APR-11 MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE HOWMEDICA OSTEONICS CORP 510(k) NO: K101072(TRADITIONAL) ATTN: KAREN ARIEMMA PHONE NO : 201 831 5718 325 CORPORATE DR. SE DECISION MADE: 11-APR-11 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LATARJET CORTICAL SCREW SET T.A.G. MEDICAL PRODUCTS CORPORATIO510(k) NO: K110763(SPECIAL) ATTN: GEORGE J HATTUB PHONE NO : 508 479 6116 291 HILLSIDE AVENUE SE DECISION MADE: 11-APR-11 SOMERSET MA 02726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAPER OXINIUM FEMORAL HEAD SMITH & NEPHEW, INC. 510(k) NO: K110101(TRADITIONAL) ATTN: SHEREEN MYERS PHONE NO : 901 396 2121 1450 EAST BROOKS RD. SE DECISION MADE: 11-APR-11 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMC-20 PORTABLE DENTAL CART MODEL AMC-20 ASEPTICO, INC. 510(k) NO: K101332(TRADITIONAL) ATTN: CHERIE A TREGONING PHONE NO : 425 487 3157 8333 216TH ST., S.E. SE DECISION MADE: 11-APR-11 WOODINVILLE WA 98072 510(k) STATEMENT DEVICE: DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604 SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K100321(TRADITIONAL) ATTN: ROSE MARINELLI PHONE NO : 302 631 8805 MS 514, PO BOX 6101 SE DECISION MADE: 12-APR-11 NEWARK DE 19714 6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO.CT CARDIAC FUNCTION SIEMENS AG 510(k) NO: K110366(TRADITIONAL) ATTN: RALF HOFFMANN PHONE NO : 51 VALLEY STREAM PKWY SE DECISION MADE: 12-APR-11 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PROPEP DELIVERY DEVICE RHYTHMLINK INTERNATIONAL, LLC 510(k) NO: K103200(TRADITIONAL) ATTN: JAMES M MEWBORNE PHONE NO : 803 252 1222 1140 FIRST STREET SOUTH SE DECISION MADE: 12-APR-11 COLUMBIA SC 29209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFUSION ADAPTER C100 CARMEL PHARMA AB. 510(k) NO: K110023(TRADITIONAL) ATTN: KJELL ANDREASSON PHONE NO : 463 170 30400 AMINOGATAN 30 SE DECISION MADE: 12-APR-11 MOLNDAL SW S431 53 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050 CORELEADER BIOTECH CO., LTD. 510(k) NO: K102943(TRADITIONAL) ATTN: IAN LI PHONE NO : 886 269 68880 19F NO. 100, SEC 1 SINTAI 5TH RD, SE DECISION MADE: 12-APR-11 TAIPEI, TAIWAN TW 22102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WALDO PATIENT MONITOR WALDO HEALTH 510(k) NO: K110334(TRADITIONAL) ATTN: ALAN R WEISS PHONE NO : 512 219 0302 4505 SPICEWOOD SPRINGS ROAD, SUITESE DECISION MADE: 12-APR-11 AUSTIN TX 78759 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDVOXEL HEARTPRO SOFTWARE APPLICATION MEDVOXEL SYSTEMS INC 510(k) NO: K103565(TRADITIONAL) ATTN: BONNIE SEWLOCHAN PHONE NO : 647 234 6643 2867 CROSSCURRENT DRIVE SE DECISION MADE: 12-APR-11 MISSISSAUGA CA L5N 6L1 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064, KAT IMPLANTS, LLC 510(k) NO: K101201(TRADITIONAL) ATTN: VITALI BONDAR PHONE NO : 603 427 0084 15 RYE STREET SUITE 115 SE DECISION MADE: 13-APR-11 PORTSMOUTH NH 03801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVA TPN BAG VALMED S.R.L. 510(k) NO: K101412(TRADITIONAL) ATTN: WALTER SVANOSIO PHONE NO : 390 342 052382 VIA PROVINCIALE 10 SE DECISION MADE: 13-APR-11 MAZZO DI VALTELLINA SO IT I 230510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MPS450 MULTIPARAMETER SIMULATOR FLUKE BIOMEDICAL 510(k) NO: K103336(TRADITIONAL) ATTN: JOHN NELSON PHONE NO : 440 498 2579 6045 COCHRAN RD. SE DECISION MADE: 13-APR-11 SOLON OH 44139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONESTEP ADULT MULTI-FUNCTION ELECTRODE ZOLL MEDICAL CORPORATION 510(k) NO: K110742(SPECIAL) ATTN: ROBERT MORSE PHONE NO : 866 639 0060 525 NARRAGANSETT PARK DRIVE SE DECISION MADE: 13-APR-11 PAWTUCKET RI 02861 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DBX DEMINERALIZED BONE MATRIX PUTTY MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K103795(TRADITIONAL) ATTN: NANCY JOY PHONE NO : 732 661 2381 125 MAY STREET SE DECISION MADE: 13-APR-11 EDISON NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DBX DEMINERALIZED BONE MATRIX PUTTY MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K103784(TRADITIONAL) ATTN: NANCY JOY PHONE NO : 732 661 2381 125 MAY STREET SE DECISION MADE: 13-APR-11 EDISON NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITEX SPACE MAINTENANCE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K110259(TRADITIONAL) ATTN: KELLY DAVIDSON PHONE NO : 901 399 3035 1800 PYRAMID PLACE SE DECISION MADE: 13-APR-11 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ODRC-DYNAMIC HIP SCREW SYSTEM ORTHOPAEDIC DEVICE RESEARCH CENTER510(k) NO: K103015(TRADITIONAL) ATTN: CHENG-KUNG CHENG PHONE NO : 886 228 267020 NO. 155, SEC. 2 LI-NUNG STREET SE DECISION MADE: 13-APR-11 TAIPEI TW 112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE) IVOCLAR VIVADENT, INC. 510(k) NO: K103556(TRADITIONAL) ATTN: DONNA MARIE HARTNETT PHONE NO : 716 691 0010 175 PINEVIEW DR. SE DECISION MADE: 13-APR-11 AMHERST NY 14228 510(k) STATEMENT DEVICE: NEWDEAL COMPRESSION PLATES NEWDEAL SAS 510(k) NO: K093914(TRADITIONAL) ATTN: STEPHEN BEIER PHONE NO : 609 936 5436 311 ENTERPRISE DR. SE DECISION MADE: 14-APR-11 PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE 3M COMPANY CORP 510(k) NO: K101468(TRADITIONAL) ATTN: LINDA JOHNSON PHONE NO : 651 737 4376 3M CENTER, BLDG 275-5W-06 SE DECISION MADE: 14-APR-11 ST. PAUL MN 55144 1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KELYNIAM CUSTOM SKULL IMPLANT (CSI) KELYNIAM GLOBAL, INC 510(k) NO: K103582(TRADITIONAL) ATTN: JAMES KETNER PHONE NO : 860 832 9331 200 MYRTLE STREET 2ND FLOOR SE DECISION MADE: 14-APR-11 NEW BRITAIN CT 06053 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SHIJIAZHUANG GLORY PLASTIC CO., LT510(k) NO: K102085(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 # 209 BEI SI HUAN ZHONG ROAD RM 16SE DECISION MADE: 14-APR-11 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VICOR PD2I ANALYZER VICOR TECHNOLOGIES, INC. 510(k) NO: K101867(TRADITIONAL) ATTN: GLEN PARK PHONE NO : 212 681 2100 261 MADISON AVE. 24TH FLOOR SE DECISION MADE: 14-APR-11 NEW YORK NY 10016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1 SMITH & NEPHEW, INC. 510(k) NO: K110240(SPECIAL) ATTN: SHEREEN MYERS PHONE NO : 901 399 6325 1450 EAST BROOKS RD. SE DECISION MADE: 14-APR-11 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT NOVABONE PRODUCTS, LLC 510(k) NO: K110368(SPECIAL) ATTN: DAVID M GAISSER PHONE NO : 386 462 7661 13631 PROGRESS BLVD SUITE 600 SE DECISION MADE: 14-APR-11 ALACHUA FL 32615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER BOSTON SCIENTIFIC CORPORATION 510(k) NO: K110887(SPECIAL) ATTN: ASHLEY PYLE PHONE NO : 508 683 4359 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 14-APR-11 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVERCROSS 0.035" OTW PTA DILATATION CATHETER EV3 INC 510(k) NO: K110319(SPECIAL) ATTN: PAULA CORDERO PHONE NO : 763 398 7344 3033 CAMPUS DRIVE SE DECISION MADE: 14-APR-11 PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APNEA RISK EVALUATION SYSTEM (ARES) ADVANCED BRAIN MONITORING INC. 510(k) NO: K110705(SPECIAL) ATTN: ADRIENNE LENZ PHONE NO : 262 290 0023 2511 FOX RIVER CIRCLE SE DECISION MADE: 14-APR-11 WAUKESHA WI 53189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE ENDOMETRIAL SUCTION CURETTE JIANGSU SUYUN MEDICAL MATERIALS CO510(k) NO: K102847(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 164 264467 P.O. BOX 237-023 SE DECISION MADE: 14-APR-11 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTERTRAK LOGIC PSC TIBIAL INSERT EXACTECH SARASOTA 510(k) NO: K110547(SPECIAL) ATTN: PATRICK HUGHES PHONE NO : 352 377 1140 2320 NW 66TH COURT SE DECISION MADE: 14-APR-11 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM REVERSE MEDICAL CORPORATION 510(k) NO: K102418(TRADITIONAL) ATTN: AMY ESKINA PHONE NO : 949 215 0600 13900 ALTON PARKWAY SUITE 123 SE DECISION MADE: 15-APR-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER TANITA CORP. 510(k) NO: K100183(TRADITIONAL) ATTN: TOSHISHIKO ISHIKAWA PHONE NO : 847 640 9241 2625 SOUTH CLEARBROOK DRIVE SE DECISION MADE: 15-APR-11 ARLINGTON HEIGHTS IL 60005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LANX SPINAL FIXATION SYSTEM LANX, INC. 510(k) NO: K103091(SPECIAL) ATTN: ANDREW LAMBORNE PHONE NO : 303 443 7500 390 INTERLOCKEN CRESCENT SUITE 890SE DECISION MADE: 15-APR-11 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIOSCULPT PTA SCORING BALLOON CATHETER ANGIOSCORE, INC. 510(k) NO: K110767(SPECIAL) ATTN: JONATHAN S KAHAN PHONE NO : 202 637 5794 555 THIRTEENTH STREET NW SE DECISION MADE: 15-APR-11 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX INTERNATIONAL BIOMEDICAL, LTD. 510(k) NO: K103527(SPECIAL) ATTN: AMY PIEPER PHONE NO : 512 873 0033 8508 CROSS PARK DR. SE DECISION MADE: 15-APR-11 AUSTIN TX 78754 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX INTERNATIONAL BIOMEDICAL, LTD. 510(k) NO: K103524(SPECIAL) ATTN: AMY PIEPER PHONE NO : 512 873 0033 8508 CROSS PARK DR. SE DECISION MADE: 15-APR-11 AUSTIN TX 78754 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER SHANTOU I NSTITUTE OF ULTRASONIC I510(k) NO: K110841(SPECIAL) ATTN: FLOWER CAI PHONE NO : 867 548 8250150 77 JINSHA ROAD SE DECISION MADE: 15-APR-11 SHANTOU, GUANGDONG CH 515041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS SPSMEDICAL SUPPLY CORP. 510(k) NO: K110152(TRADITIONAL) ATTN: GARY J SOCOLA PHONE NO : 585 359 0130 6789 WEST HENRIETTA RD SE DECISION MADE: 15-APR-11 RUSH NY 14543 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS CARDINAL HEALTH, INC. 510(k) NO: K110921(TRADITIONAL) ATTN: TATYANA BOGDAN PHONE NO : 847 887 2325 1430 WAUKEGAN ROAD SE DECISION MADE: 15-APR-11 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ATMOS E 201 THORAX AND ATMOS S 201 THORAX ATMOS INC. 510(k) NO: K103042(TRADITIONAL) ATTN: MARCO SCHLEGEL PHONE NO : 610 740 1011 3717 HUCKLEBERRY ROAD SE DECISION MADE: 15-APR-11 ALLENTOWN PA 18104 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LI ZIMMER, INC. 510(k) NO: K103662(SPECIAL) ATTN: REBECCA BROOKS PHONE NO : 574 371 8033 P.O. BOX 708 SE DECISION MADE: 15-APR-11 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTISTE SOLUTION WITH SYS_VB50 UPDATE SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K103606(TRADITIONAL) ATTN: CHRISTINE DUNBAR PHONE NO : 925 602 8157 4040 NELSON AVE. SE DECISION MADE: 15-APR-11 CONCORD CA 94520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K100344(TRADITIONAL) ATTN: ROSE MARINELLI PHONE NO : 302 631 8805 MS 514, PO BOX 6101 SE DECISION MADE: 18-APR-11 NEWARK DE 19714 6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFILL INTERVERTEBRAL BODY FUSION DEVICE PINNACLE SPINE GROUP, LLC 510(k) NO: K103729(TRADITIONAL) ATTN: REBECCA K PINE PHONE NO : 760 809 5178 1601 ELM STREET, SUITE 300 SE DECISION MADE: 18-APR-11 DALLAS TX 75201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AOI CRANIAL HELMET ADVANCED ORTHOPRO INC. 510(k) NO: K103362(TRADITIONAL) ATTN: MOHAMAD MANSOORI PHONE NO : 317 924 4444 1820 N. ILLINOIS ST. SE DECISION MADE: 18-APR-11 INDIANAPOLIS IN 46202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESPICHAMBER VALVED HOLDING CHAMBER TRUDELL MEDICAL INTL. 510(k) NO: K110136(TRADITIONAL) ATTN: DARRYL FISHER PHONE NO : 519 455 7060 725 THIRD ST. SE DECISION MADE: 18-APR-11 LONDON, ONTARIO CA N5V 5G4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS GE MEDICAL SYSTEMS, LLC 510(k) NO: K093581(TRADITIONAL) ATTN: TRACEY ORTIZ PHONE NO : 414 544 3026 3000 N GRANDVIEW BLVD. SE DECISION MADE: 19-APR-11 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WEXLER VASCULAR CLAMP SERIES MICROSURGICAL LABORATORIES,INC.DBA510(k) NO: K110148(TRADITIONAL) ATTN: LISA S JONES PHONE NO : 713 664 6775 540 COLLEGE STREET SE DECISION MADE: 19-APR-11 BELLAIRE TX 77401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONSERVE BIO FOAM SHELL WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K110029(TRADITIONAL) ATTN: DANIELLE MUELLER PHONE NO : 901 290 5904 5677 AIRLINE ROAD SE DECISION MADE: 19-APR-11 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA JIEYING LABORATORY INC. 510(k) NO: K102480(TRADITIONAL) ATTN: GRACE HOLLAND PHONE NO : 949 262 0411 9722 AVE. SAUSALITO SE DECISION MADE: 19-APR-11 IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES WEALTH ON (JIANGSU) CO., LTD 510(k) NO: K110219(TRADITIONAL) ATTN: CHENGYU SHEN PHONE NO : 608 217 9358 5 CAREY STREET SE DECISION MADE: 19-APR-11 PENNINGTON NJ 08534 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES ZIBO YUECHUAN PLASTIC PRODUCTS CO.510(k) NO: K110338(TRADITIONAL) ATTN: FRANK LIU PHONE NO : 909 548 4828 12390 EAST END AVENUE SE DECISION MADE: 19-APR-11 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPACELABS SMART DISCLOSURE SYSTEM SPACELABS HEALTHCARE 510(k) NO: K110779(SPECIAL) ATTN: THOMAS KROENKE PHONE NO : 303 956 4232 P.O. BOX 3018 SE DECISION MADE: 19-APR-11 NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVERON CENTRAL DISPLAY STATION (CDS) EARLYSENSE LTD. 510(k) NO: K110521(SPECIAL) ATTN: DALIA ARGAMAN PHONE NO : 972 375 22330X160 TZVI 12 SE DECISION MADE: 19-APR-11 RAMAT-GAN IS 52504 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NATUS SLEEPWORKS, MODEL 104017 EXCEL-TECH LTD. (XLTEK) 510(k) NO: K090277(TRADITIONAL) ATTN: GOLDY SINGH PHONE NO : 905 829 5300 2568 BRISTOL CIR. SE DECISION MADE: 19-APR-11 OAKVILLE, ONTARIO CA L6H 5S1 510(k) STATEMENT DEVICE: PARIETEX OPTIMIZED COMPOSTIE MESH SOFRADIM PRODUCTION 510(k) NO: K110815(SPECIAL) ATTN: JAMES MCMAHON PHONE NO : 781 839 1787 BIOSURGERY 15 CROSBY DRIVE SE DECISION MADE: 19-APR-11 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES) SOFRADIM PRODUCTION 510(k) NO: K110816(SPECIAL) ATTN: JAMES MCMAHON PHONE NO : 781 839 1787 BIOSURGERY 15 CROSBY DRIVE SE DECISION MADE: 19-APR-11 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER 3M COMPANY-3M HEALTH CARE 510(k) NO: K103277(TRADITIONAL) ATTN: SUZANNE LEUNG PHONE NO : 651 575 8052 3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 19-APR-11 ST. PAUL MN 55133 1006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIXEL CO2 LASER BEIJING SYNTECH LASER CO., LTD. 510(k) NO: K110434(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 122 815850 P.O. BOX 237-023 SE DECISION MADE: 19-APR-11 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FLEXIBLE CARDIAC COIL LBDS HOLDING COMPANY 510(k) NO: K110487(TRADITIONAL) ATTN: RICHARD BRYANT PHONE NO : 214 564 0146 6440 SKY POINTE DR SUITE 140 SE DECISION MADE: 19-APR-11 LAS VEGAS NV 89131 510(k) STATEMENT DEVICE: BLUE SKY BIO DENTAL IMPLANT SYSTEM BLUE SKY BIO, LLC 510(k) NO: K102034(TRADITIONAL) ATTN: ALBERT ZICKMANN PHONE NO : 847 548 8499 888 E BELVIDERE RD. SUITE 212 SE DECISION MADE: 19-APR-11 GRAYSLAKE IL 60030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FDI GLUCOSE CONTROL SOLUTION FOR AVIVA FUJIREBIO DIAGNOSTICS, INC 510(k) NO: K110436(TRADITIONAL) ATTN: KENT PRUETT PHONE NO : 830 372 1391 940 CROSSROADS BLVD. SE DECISION MADE: 20-APR-11 SEGUIN TX 78155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPUTED DENTAL RADIOGRAPHY SCHICK TECHNOLOGIES, INC. 510(k) NO: K110768(SPECIAL) ATTN: SCOTT DOYLE PHONE NO : 718 937 5765 30-30 47TH AVE. SE DECISION MADE: 20-APR-11 LONG ISLAND CITY NY 11101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELL-TISSUE CONVERTER (CTC) SYRINGE WITH NEEDLE RONGSHAN LI 510(k) NO: K110112(TRADITIONAL) ATTN: RONGSHAN LI PHONE NO : 414 241 1022 11 GEORGETOWN CT. SE DECISION MADE: 20-APR-11 BASKING RIDGE NJ 07920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UCP DRUG SCREENING TEST CUPS UCP BIOSCIENCES, INC. 510(k) NO: K110515(SPECIAL) ATTN: NANCY CHEN PHONE NO : 408 392 0064 1445 KOLL CIRCLE, STE. 111 SE DECISION MADE: 20-APR-11 SAN JOSE CA 95112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRE BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORPORATION 510(k) NO: K110833(SPECIAL) ATTN: JANIS TARANTO PHONE NO : 508 683 4560 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 20-APR-11 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPI TITANIUM BASE FOR CAD/CAM THOMMEN MEDICAL, AG 510(k) NO: K102804(TRADITIONAL) ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235 11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 20-APR-11 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2, UNILENS CORP., USA 510(k) NO: K110452(SPECIAL) ATTN: ALAN J FRAZER PHONE NO : 727 544 2531 10431 72ND ST. NORTH SE DECISION MADE: 20-APR-11 LARGO FL 33777 510(k) STATEMENT DEVICE: SATURN 8000-GS NEW MEDICAL CO., LTD. 510(k) NO: K110210(TRADITIONAL) ATTN: JUN-HSIUNG LIN PHONE NO : 909 244 6562 1460 ATTERBURY DR. SE DECISION MADE: 20-APR-11 WALNUT CA 91789 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYMBIA.NET SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K110844(SPECIAL) ATTN: ELAINE CHANG PHONE NO : 847 304 7516 2501 NORTH BARRINGTON RD. SE DECISION MADE: 20-APR-11 HOFFMAN ESTATES IL 60192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESUSCITATION UNIT 105 ATOM MEDICAL CORPORATION 510(k) NO: K103317(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 20-APR-11 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM PATHWAY MEDICAL TECHNOLOGIES, INC.510(k) NO: K110626(SPECIAL) ATTN: BRIAN CLEARY PHONE NO : 425 636 4079 10801 120TH AVENUE NE SE DECISION MADE: 20-APR-11 KIRKLAND WA 98033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOPIP PATIENT CIRCUIT WITH PEEP NEOFORCE GROUP, INC. 510(k) NO: K103833(TRADITIONAL) ATTN: MONICA FERRANTE PHONE NO : 215 672 6800 35 COMMERCE DR. SE DECISION MADE: 20-APR-11 IVYLAND PA 18974 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RETCAM 3 OPTHALMIC IMAGING SYSTEM CLARITY MEDICAL SYSTEMS 510(k) NO: K102859(TRADITIONAL) ATTN: GARY A SEEGER PHONE NO : 925 463 7984 5775 WEST LAS POSITAS BLVD. SUITE SE DECISION MADE: 20-APR-11 PLEASANTON CA 94588 4084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOSCAF TEXAS INNOVATIVE MEDICAL DEVICES (510(k) NO: K101827(TRADITIONAL) ATTN: JERRY CHANG PHONE NO : 352 256 2707 4808 RESEARCH DRIVE SE DECISION MADE: 20-APR-11 SAN ANTONIO TX 78240 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELECTRA CS LEAD INTRODUCER SYSTEM BIOTRONIK, INC. 510(k) NO: K110461(SPECIAL) ATTN: JON BRUMBAUGH PHONE NO : 888 345 0374 6024 JEAN ROAD SE DECISION MADE: 20-APR-11 LAKE OSWEGO OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM MEDLINE INDUSTRIES, INC. 510(k) NO: K103602(TRADITIONAL) ATTN: MATT CLAUSEN PHONE NO : 847 643 4785 ONE MEDLINE PLACE SE DECISION MADE: 21-APR-11 MUNDELEIN IL 60060 4486 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM SYNTHES USA 510(k) NO: K110125(TRADITIONAL) ATTN: CHRISTOPHER HACK, ESQ. PHONE NO : 610 719 6940 1301 GOSHEN PKWY SE DECISION MADE: 21-APR-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15) ORTHOGEM LIMITED 510(k) NO: K110787(SPECIAL) ATTN: WE-JEN LO PHONE NO : 441 159 505721 BIOCITY, PENNYFOOT STREET SE DECISION MADE: 21-APR-11 NOTTINGHAM UK NG1 1GF 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HELENA SYSTEM ROYAL OAK MEDICAL DEVICES 510(k) NO: K110177(TRADITIONAL) ATTN: MATTHEW KROLL PHONE NO : 248 628 2830 39533 WOODWARD AVENUE SE DECISION MADE: 21-APR-11 BLOOMFIELD HILLS MI 48304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IFUSE IMPLANT SYSTEM SI-BONE, INC. 510(k) NO: K110838(SPECIAL) ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET STREET 29TH FLOOR SE DECISION MADE: 21-APR-11 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM INTRA-LOCK INTERNATIONAL, INC. 510(k) NO: K103194(ABBREVIATED) ATTN: ANGELA BLACKWELL PHONE NO : 704 450 9934 6560 WEST ROGERS CIRCLE SE DECISION MADE: 21-APR-11 BOCA RATON FL 33487 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BODYFLOW P2CH PHYSIOMED ELEKTROMEDIZIN AG 510(k) NO: K100862(TRADITIONAL) ATTN: BIRGIT SCHMID PHONE NO : 499 126 258717 HUTWEIDE 10 SE DECISION MADE: 21-APR-11 SCHNAITTACH/LAIPERSDORF GM D-91510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CURVE IMAGE CURVE DENTAL, INC. 510(k) NO: K110139(TRADITIONAL) ATTN: CAROLINE TONTINI PHONE NO : 512 327 9997 611 WEST 5TH STREET, THIRD FLOOR SE DECISION MADE: 21-APR-11 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0 CEPHEID 510(k) NO: K103766(TRADITIONAL) ATTN: KERRY J FLOM PHONE NO : 408 400 8460 904 CARIBBEAN DRIVE SE DECISION MADE: 21-APR-11 SUNNYVALE CA 94089 1189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JETPACK 2.0 PHILIPS MEDICAL SYSTEMS (CLEVELAND510(k) NO: K111024(TRADITIONAL) ATTN: LORI R PETERSON PHONE NO : 408 468 3042 3860 NORTH 1ST STREET SE DECISION MADE: 21-APR-11 SAN JOSE CA 95134 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EASYRA UREA NITROGEN AND CREATININE REAGENTS MEDICA CORP. 510(k) NO: K110675(TRADITIONAL) ATTN: PHOTIOS MAKRIS PHONE NO : 781 541 7443 5 OAK PARK DRIVE SE DECISION MADE: 21-APR-11 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISION LIQUID OXYGEN SYSTEM PRECISION MEDICAL, INC. 510(k) NO: K103324(TRADITIONAL) ATTN: JAMES PARKER PHONE NO : 610 262 6090 300 HELD DRIVE SE DECISION MADE: 21-APR-11 NORTHAMPTON PA 18067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL SYNTEX HEALTHCARE PRODUCTS CO., LT510(k) NO: K103770(TRADITIONAL) ATTN: KATHY LIU PHONE NO : 909 590 1611 3973 SCHAEFER AVE SE DECISION MADE: 21-APR-11 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GSP NEONATAL THYROXINE (T4) WALLAC OY, A SUBSIDIARY OF PERKINE510(k) NO: K103484(TRADITIONAL) ATTN: SUSAN K HAMANN PHONE NO : 781 663 5872 940 WINTER STREET SE DECISION MADE: 22-APR-11 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C.T.M. MOBILITY SCOOTER HS515(3W) C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K110567(TRADITIONAL) ATTN: SHEILA RAMERMAN PHONE NO : 541 683 3017 927 THRONE DRIVE SE DECISION MADE: 22-APR-11 EUGENE OR 97402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENX REVOLUTION VENX LLC 510(k) NO: K110355(TRADITIONAL) ATTN: IRA DUESLER PHONE NO : 315 868 5645 4700 S. OVERLAND DRIVE SE DECISION MADE: 22-APR-11 TUCSON' AZ 85714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C.T.M. MOBILITY SCOOTER - MODEL HS 118 C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K110395(TRADITIONAL) ATTN: SHEILA RAMERMAN PHONE NO : 541 683 3017 927 THRONE DRIVE SE DECISION MADE: 22-APR-11 EUGENE OR 97402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVISION PROTHESIS SMITH & NEPHEW, INC. 510(k) NO: K110837(SPECIAL) ATTN: MEGAN BEVILL PHONE NO : 901 399 5340 1450 EAST BROOKS RD. SE DECISION MADE: 22-APR-11 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WINCO STRETCHAIR WINCO MFG., LLC 510(k) NO: K110671(TRADITIONAL) ATTN: JIM ANKOVIAK PHONE NO : 352 854 2929 5516 SW 1st Ln SE DECISION MADE: 22-APR-11 Ocala FL 34474 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR RUBBERCARE PROTECTION PRODUCTS (M)510(k) NO: K102902(TRADITIONAL) ATTN: LIM KWEE SHYAN PHONE NO : 606 677 2781 OFF JALAN SENAWANG EMPAT SENAWANG SE DECISION MADE: 22-APR-11 SEREMBAN, NEGERI SEMBILAN MY 70510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POSEY BED J. T. POSEY CO. 510(k) NO: K103817(TRADITIONAL) ATTN: ROBERT KELLEHER PHONE NO : 626 454 2109 5635 PECK RD. SE DECISION MADE: 22-APR-11 ARCADIA CA 91006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVS ANCHOR-C CERVICAL CAGE SYSTEM STRYKER SPINE 510(k) NO: K102606(TRADITIONAL) ATTN: KIMBERLY LANE PHONE NO : 201 760 8215 2 PEARL COURT SE DECISION MADE: 22-APR-11 ALLENDALE NJ 07401 1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVADER MTHFR 1298 HOLOGIC, INC. 510(k) NO: K100496(TRADITIONAL) ATTN: RANDALL J COVILL PHONE NO : 508 263 8853 250 CAMPUS DRIVE SE DECISION MADE: 25-APR-11 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTECTIVE RESTRAINT MEDI-TECH INTL. CORP. 510(k) NO: K110377(TRADITIONAL) ATTN: MARILYN GEIGER PHONE NO : 414 570 8880 26 COURT ST., SUITE 1301 SE DECISION MADE: 25-APR-11 BROOKLYN NY 11242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLCART B B. BRAUN AVITUM AG 510(k) NO: K102194(TRADITIONAL) ATTN: ANGELA CARAVELLA PHONE NO : 610 266 0500 901 MARCON BLVD. SE DECISION MADE: 25-APR-11 ALLENTOWN PA 18109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAPRO PLUS INTERMITTENT CATHETER HOLLISTER, INCORPORATED 510(k) NO: K110862(SPECIAL) ATTN: CHRIS STUKEL PHONE NO : 847 918 3452 2000 HOLLISTER DRIVE SE DECISION MADE: 26-APR-11 ;IBERTYVILLE IL 60048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVAKONE SPHERICAL AND TORIC LENSES ALDEN OPTICAL LABS., INC. 510(k) NO: K102557(TRADITIONAL) ATTN: CHARLES H CREIGHTON PHONE NO : 716 937 9181 13295 BROADWAY SE DECISION MADE: 26-APR-11 ALDEN NY 14004 510(k) STATEMENT DEVICE: AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION GE HEALTHCARE 510(k) NO: K110834(SPECIAL) ATTN: HELEN PENG PHONE NO : 262 548 5091 3000 NORTH.GRANDVIEW BLVD. W1140 SE DECISION MADE: 26-APR-11 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZEUS ELISA HSV GC-I IGG TEST SYSTEM ZEUS SCIENTIFIC, INC. 510(k) NO: K103363(TRADITIONAL) ATTN: EWA NADOLCZAK PHONE NO : 908 526 3744 200 EVANS WAY SE DECISION MADE: 26-APR-11 BRANCHBURG NJ 08876 510(k) STATEMENT DEVICE: DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM EDAN INSTRUMENTS, INC. 510(k) NO: K110999(TRADITIONAL) ATTN: RANDY JIANG PHONE NO : 867 552 6858736 4/F, NEW ENERGY BLDG., 2009 NANYOUSE DECISION MADE: 26-APR-11 NANSHAN, GUANGDONG CH 518054 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DISPOSABLE INSULIN SYRINGE WENZHOU WUZHOU IMPORT & EXPORT CO.510(k) NO: K110421(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 164 264467 P.O. BOX 237-023 SE DECISION MADE: 26-APR-11 BINGYI XIANG, ZHEJIANG CH 32500510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRESTODR 4143 CMT MEDICAL TECHNOLOGIES, LTD. 510(k) NO: K110849(SPECIAL) ATTN: SHLOMI DINES PHONE NO : 972 485 66220 INDUSTRIAL PARK P.O.B. 111 SE DECISION MADE: 26-APR-11 YOQNEAM ILIT IS 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPELLA CONTROLLER WITH FLOW CONTROL ABIOMED, INC. 510(k) NO: K110845(SPECIAL) ATTN: ROBERT STEWART PHONE NO : 978 646 1567 22 CHERRY HILL DR. SE DECISION MADE: 27-APR-11 DANVERS MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIVERSAL DIGITAL INTERFACE (UDI) 1717 MERIDIAN MEDICAL SYSTEMS, LLC 510(k) NO: K103599(TRADITIONAL) ATTN: ARIEL MARCIANO PHONE NO : 407 719 9853 325 HARRIS DRIVE SE DECISION MADE: 27-APR-11 AURORA OH 44202 510(k) STATEMENT DEVICE: AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM TORNIER, INC. 510(k) NO: K110865(SPECIAL) ATTN: BRAHIM HADRI PHONE NO : 978 232 9997 100 CUMMINGS CENTER, SUITE 444C SE DECISION MADE: 27-APR-11 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIPLEX ER. YAG / ND: YAG SYSTEM SANDSTONE MEDICAL TECHNOLOGIES, LL510(k) NO: K110502(TRADITIONAL) ATTN: MARK ROHRER PHONE NO : 205 290 8251 105 CITATION COURT SE DECISION MADE: 27-APR-11 HOMEWOOD AL 35209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES HEBEI TENGDA PLASTIC CO., LTD 510(k) NO: K102151(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606 BLDG.1 JIANXIANG YUA NO.SE DECISION MADE: 27-APR-11 SHIJIAZHUANG CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FILMARRAY RP PANEL IDAHO TECHNOLOGY, INC. 510(k) NO: K110764(TRADITIONAL) ATTN: BETH LINGENFELTER PHONE NO : 801 736 6354 390 WAKARA WAY SE DECISION MADE: 27-APR-11 SALT LAKE CITY UT 84108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY SOLARC SYSTEMS INC. 510(k) NO: K103204(TRADITIONAL) ATTN: BRUCE ELLIOTT PHONE NO : 705 739 3048 1515 SNOW VALLEY ROAD SE DECISION MADE: 27-APR-11 MINESING,ONTARIO CA L0L 1Y3 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUBESCAN / BIOCON-700 MCUBE TECHNOLOGY CO., LTD. 510(k) NO: K111021(TRADITIONAL) ATTN: SEUNGTAI KIM PHONE NO : 822 342 17780 803 SHINNAE-TECHNOTOWN 485 SANGBONSE DECISION MADE: 27-APR-11 CHUNGNANG-KU, SEOUL KS 131-220 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 BECKMAN COULTER, INC. 510(k) NO: K103842(TRADITIONAL) ATTN: MARINE BOYAJIAN PHONE NO : 714 961 6536 250 S. KRAEMER BOULEVARD MAIL STOPSE DECISION MADE: 27-APR-11 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHTY DD INFUSION SET MEDX-SET LTD 510(k) NO: K110282(TRADITIONAL) ATTN: RAYMOND KELLY PHONE NO : 603 595 0095 56B SHAWDOW DR. SE DECISION MADE: 27-APR-11 HUDSON NH 03051 510(k) STATEMENT DEVICE: TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS THUNDER TIGER CORP. 510(k) NO: K102517(TRADITIONAL) ATTN: JO LEE PHONE NO : 886 423 591616 NO. 7, 6TH ROAD INDUSTRY PARK SE DECISION MADE: 27-APR-11 TAICHUNG TW 40755 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET DIAZYME LABORATORIES 510(k) NO: K103557(TRADITIONAL) ATTN: ABHIJIT DATTA PHONE NO : 858 455 4762 12889 GREGG COURT SE DECISION MADE: 27-APR-11 POWAY CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PCL TIGHTROPE ARTHREX, INC. 510(k) NO: K110123(TRADITIONAL) ATTN: COURTNEY SMITH PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 28-APR-11 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP APEX BIOTECHNOLOGY CORP. 510(k) NO: K102481(SPECIAL) ATTN: LISA LIU PHONE NO : 866 356 41952 NO. 7, LI-HSIN ROAD V, HSINCHU SCISE DECISION MADE: 28-APR-11 HSINCHU TW 30078 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FEMVUE SALINE-AIR DEVICE FEMASYS INC. 510(k) NO: K110288(TRADITIONAL) ATTN: LISA PEACOCK PHONE NO : 770 500 3910 5000 RESEARCH COURT STE .100 SE DECISION MADE: 28-APR-11 SUWANEE GA 30024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10 MICROVENTION, INC. 510(k) NO: K103758(SPECIAL) ATTN: LARAINE PANGELINA PHONE NO : 714 247 8150 1311 VALENCIA AVE SE DECISION MADE: 28-APR-11 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES HEBEI TENGDA PLASTIC CO., LTD 510(k) NO: K102152(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606 BLDG.1 JIANXIANG YUA NO.SE DECISION MADE: 28-APR-11 SHIJIAZHUANG CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PEN NEEDLE BECTON DICKINSON AND COMPANY (BD) 510(k) NO: K110105(SPECIAL) ATTN: PASQUALE AMATO PHONE NO : 201 847 4513 1 BECTON DRIVE. MC372 SE DECISION MADE: 28-APR-11 FRANKLIN LAKES NJ 07417 1885 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONE DAY FLAT PACK MENICON CO. LTD. 510(k) NO: K102895(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970 243 5490 806 KIMBALL AVENUE SE DECISION MADE: 28-APR-11 GRAND JUNCTION CO 81501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMARC FIDUCIAL MARKER CARBON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K110772(TRADITIONAL) ATTN: ANDREW J ADAMS PHONE NO : 651 653 8512 1290 HAMMOND RD. SE DECISION MADE: 28-APR-11 ST. PAUL MN 55110 5867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENAISSANCE SYSTEM MAZOR ROBOTICS LTD 510(k) NO: K110911(SPECIAL) ATTN: AHAVA STEIN PHONE NO : 972 976 70002 20 HATA'AS ST. SE DECISION MADE: 28-APR-11 KFAR SABA IS 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRA LASER SYSTEM LUTRONIC CORPORATION 510(k) NO: K103455(SPECIAL) ATTN: JHUNG WON VOJIR PHONE NO : 609 275 1565 51 EVERETT DRIVE, UNIT A-50 SE DECISION MADE: 28-APR-11 PRINCETON JUNCTION NJ 08550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K103683(ABBREVIATED) ATTN: GARO MIMARYAN PHONE NO : 914 524 3270 511 BENEDICT AVENUE SE DECISION MADE: 28-APR-11 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL R & D SYSTEMS, INC. 510(k) NO: K101578(TRADITIONAL) ATTN: NANCY RING PHONE NO : 612 656 4533 614 MCKINLEY PL., N.E. SE DECISION MADE: 28-APR-11 MINNEAPOLIS MN 55413 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUTTING EDGE SPINE INTERBODY FUSION DEVICE CUTTING EDGE SPINE, LLC 510(k) NO: K102957(TRADITIONAL) ATTN: JOHN KAPITAN PHONE NO : 704 843 7852 100 E. SOUTH MAIN STREET PO BOX 14SE DECISION MADE: 28-APR-11 MATTHEWS NC 28173 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AGACHAMBER SPACER AGAPLASTIC IND. COM. LTDA. 510(k) NO: K101348(TRADITIONAL) ATTN: MARIA F GRIFFIN PHONE NO : 704 843 1675 55 NORTHERN BLVD SUITE 200 SE DECISION MADE: 29-APR-11 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES CHANGDA PLASTIC PRODUCT CO., LTD 510(k) NO: K103196(TRADITIONAL) ATTN: WANG LIN PHONE NO : 86 310 3096390 WANGZHUANG TOWN, LI COUNTY SE DECISION MADE: 29-APR-11 HANDAN CITY CH 056001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORTROSS BONE VOID FILLER PIONEER SURGICAL TECHNOLOGY 510(k) NO: K110561(SPECIAL) ATTN: DAVID J COLLETTE PHONE NO : 858 792 1235 11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 29-APR-11 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REUSABLE TEST PACK FOR DANA EMULATING INDICATORS DANA PRODUCTS, INC. 510(k) NO: K110253(TRADITIONAL) ATTN: HARRY BALA PHONE NO : 847 455 2881 7 COREY DR. SE DECISION MADE: 29-APR-11 SOUTH BARRINGTON IL 60010 510(k) STATEMENT DEVICE: KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS KIMBERLY-CLARK CORP. 510(k) NO: K110455(ABBREVIATED) ATTN: ANN WATERHOUSE PHONE NO : 678 352 6719 1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 29-APR-11 ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW TOTAL 510(k)s THIS PERIOD 240 TOTAL WITH SUMMARIES 226 TOTAL WITH STATEMENTS 14