
February 2011 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD February 2011 DEVICE: VISULAS TRION LASER SYSTEM WITH THE VITE OPTION CARL ZEISS MEDITEC AG 510(k) NO: K103056(TRADITIONAL) ATTN: JUDITH A BRIMACOMBE PHONE NO : 925 557 4616 5160 HACIENDA DRIVE SE DECISION MADE: 01-FEB-11 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER TELEFLEX MEDICAL, INC. 510(k) NO: K102238(SPECIAL) ATTN: SUZANNE SCHORLE PHONE NO : 610 378 0131 2400 BERNVILLE ROAD SE DECISION MADE: 01-FEB-11 READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES INTERVASCULAR, SAS 510(k) NO: K103347(SPECIAL) ATTN: PHILIPPE BENSIMON PHONE NO : 334 420 87784 ZONE INDUSTRIELLE ATHELIA I SE DECISION MADE: 02-FEB-11 LACIOTAT FR 13705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYPO CLENZ WOUND WASH MODEL 100 PPM NEVOA LIFE SCIENCES, LLC 510(k) NO: K100948(TRADITIONAL) ATTN: S. DAVID PIPER, PE PHONE NO : 916 483 3687 4807 EL CAMINO AVE SUITE C SE DECISION MADE: 02-FEB-11 CARMICHAEL CA 95608 510(k) STATEMENT DEVICE: SURGIAID MAXIGEN BIOTECH, INC. 510(k) NO: K100927(TRADITIONAL) ATTN: JENNIFER REICH PHONE NO : 928 773 6340 2904 N BOLDT AVE SE DECISION MADE: 02-FEB-11 FLAGSTAFF AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PET-512MC TRANSESOPHAGEAL TRANSDUCER TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K103629(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714 730 5000 2441 MICHELLE DR. P.O. BOX 2068 SE DECISION MADE: 02-FEB-11 TUSTIN CA 92781 2068 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCULAIRE COMPRESSION SYSTEM VENOUS HEALTH SYSTEMS, INC. 510(k) NO: K103113(TRADITIONAL) ATTN: ALBERT BONISKE PHONE NO : 408 400 0856 155-A MOFFETT PARK DRIVE SUITE #21SE DECISION MADE: 02-FEB-11 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SECURVIEW DX DIAGNOSTIC WORKSTATION HOLOGIC, INC. 510(k) NO: K103385(SPECIAL) ATTN: GAIL YAEKER-DAUNIS PHONE NO : 203 731 8337 37 APPLE RIDGE ROAD SE DECISION MADE: 02-FEB-11 DANBURY CT 06810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL ACON LABORATORIES, INC. 510(k) NO: K103387(TRADITIONAL) ATTN: RICHARD LENART PHONE NO : 858 875 8019 10125 MESA RIM RD. SE DECISION MADE: 02-FEB-11 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARSTASIS ONE LATCHWIRE ACCESS SYSTEM ARSTASIS, INC. 510(k) NO: K103143(SPECIAL) ATTN: DEBRA COGAN PHONE NO : 650 508 1549 1021 HOWARD AVE SUITE C SE DECISION MADE: 02-FEB-11 SAN CARLOS CA 94070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE COOK, INC. 510(k) NO: K110009(SPECIAL) ATTN: KAREN BRADBURN PHONE NO : 812 339 2235 750 DANIELS WAY P.O. BOX 489 SE DECISION MADE: 02-FEB-11 BLOOMINGTON IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FINESS ENDOSCOPE STERILIZATION TRAY ENTELLUS MEDICAL, INC. 510(k) NO: K103213(TRADITIONAL) ATTN: KAREN E PETERSON PHONE NO : 763 463 7066 6705 WEDGWOOD COURT NORTH SE DECISION MADE: 02-FEB-11 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PEDIACYN ATOPIC DERMATITIS HYDROGEL OCULUS INNOVATIVE SCIENCES, INC. 510(k) NO: K102945(TRADITIONAL) ATTN: ANTOINETTE DOUGLAS PHONE NO : 707 559 2445 1135 N. MC DOWELL BLVD SE DECISION MADE: 02-FEB-11 PETALUMA CA 94954 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGNATURE PLANNER; SIGNATURE GUIDES MATERIALISE N.V. 510(k) NO: K102795(TRADITIONAL) ATTN: ALEXANDRA RAZZHIVINA PHONE NO : 32 16 396280 TECHNOLOGIELAAN 15 SE DECISION MADE: 02-FEB-11 LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLARIS SPINAL SYSTEM BIOMET SPINE 510(k) NO: K103393(SPECIAL) ATTN: VIVIAN KELLY PHONE NO : 973 299 9300 100 INTERPACE PARKWAY SE DECISION MADE: 02-FEB-11 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTICARE SAFETY INSULIN SYRINGE ULTI-MED INTL., INC. 510(k) NO: K103011(TRADITIONAL) ATTN: MARY BETH HENDERSON PHONE NO : 952 227 3380 5353 WAYZATA BOULEVARD SUITE 505 SE DECISION MADE: 02-FEB-11 MINNEAPOLIS MN 55416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NASAL CEASE CATALINA, INC. 510(k) NO: K102742(TRADITIONAL) ATTN: RICHARD J FREER PHONE NO : 804 285 7034 8110 WESTBURY DR. SE DECISION MADE: 02-FEB-11 RICHMOND VA 23229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFIL COMPOSITES (PROFIL, PROFIL FLOW) SILMET LTD. 510(k) NO: K103190(TRADITIONAL) ATTN: MOSHE ZALSMAN PHONE NO : 972 353 31474 12 HASADNA SE DECISION MADE: 02-FEB-11 OR YEHUDA IS 60200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) IMRIS, INC. 510(k) NO: K103506(TRADITIONAL) ATTN: THOMAS M TASKERIS PHONE NO : 301 330 2076 16809 BRIARDALE ROAD SE DECISION MADE: 02-FEB-11 ROCKVILLE MD 20855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TALON SPINAL SYSTEM SPINE360 510(k) NO: K102995(SPECIAL) ATTN: DAVE LAMB PHONE NO : 512 327 6403 5000 PLAZA ON THE LAKE SUITE 305 SE DECISION MADE: 02-FEB-11 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K070049(TRADITIONAL) ATTN: JANET C KAY PHONE NO : 781 699 4475 920 WINTER ST. SE DECISION MADE: 03-FEB-11 WALTHAM MA 02451 1457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONICA AN24 MONICA HEALTHCARE 510(k) NO: K101801(TRADITIONAL) ATTN: IAN HOW PHONE NO : 44 115 9124541 PENNYFOOT STREET SE DECISION MADE: 03-FEB-11 NOTTINGHAM UK NG1 1GF 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS GRI MEDICAL & ELECTRONIC TECHNOLOG510(k) NO: K102652(TRADITIONAL) ATTN: PENNY NORTHCUTT PHONE NO : 678 428 6978 717 LAKEGLEN DRIVE SE DECISION MADE: 03-FEB-11 SUWANEE GA 30024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUTRAZORB VISIONARY MEDICAL SUPPLIES, INC. 510(k) NO: K102592(ABBREVIATED) ATTN: GARY SYRING PHONE NO : 608 877 2635 800 LEVANGER LN. SE DECISION MADE: 03-FEB-11 STOUGHTON WI 53589 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BALL ABUTMENT SYSTEM MEGAGEN CO., LTD. 510(k) NO: K101890(TRADITIONAL) ATTN: JOYCE BANG PHONE NO : 714 525 0114 325 N. PUENTE STREET UNIT B SE DECISION MADE: 03-FEB-11 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BUTLER CALCI-FLOR PROPHYLAXIS PASTE SUNSTAR AMERICAS, INC. 510(k) NO: K102053(TRADITIONAL) ATTN: CARL JENKINS PHONE NO : 847 234 7500 10 E. SCANTON AVE SUITE 201 SE DECISION MADE: 03-FEB-11 LAKE BLUFF IL 60044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT EXAMINATION GLOVES THAI HUA HOLDING CO., LTD. 510(k) NO: K102838(TRADITIONAL) ATTN: KOK-KEE HON PHONE NO : 703 941 7656 6324 MEETINGHOUSE WAY SE DECISION MADE: 03-FEB-11 ALEXANDRIA VA 22312 1718 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS MENICON CO. LTD. 510(k) NO: K103561(TRADITIONAL) ATTN: BEVERLEY D VENUTI PHONE NO : 978 658 6888 187 BALLARDVALE STREET SUITE 180 SE DECISION MADE: 03-FEB-11 WILMINGTON MA 01887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS SMITH & NEPHEW ENDOSCOPY, INC. 510(k) NO: K103309(TRADITIONAL) ATTN: KATHLEEN SOLOMON PHONE NO : 978 749 1605 150 MINUTEMAN ROAD SE DECISION MADE: 03-FEB-11 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS AQUA SCIENCES, INC. 510(k) NO: K102892(TRADITIONAL) ATTN: MICHAEL J TODD PHONE NO : 716 695 1200 565 FILLMORE AVENUE SE DECISION MADE: 03-FEB-11 TONAWANDA NY 14150 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT ATLANTIS COMPONENTS, INC. 510(k) NO: K103020(TRADITIONAL) ATTN: BETSY BROWN PHONE NO : 847 560 4406 8944 TAMAROA TERRACE SE DECISION MADE: 03-FEB-11 SKOKIE IL 60076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT HOWMEDICA OSTEONICS CORP 510(k) NO: K103233(TRADITIONAL) ATTN: AVITAL MERL-MARGULIES PHONE NO : 201 831 6365 325 CORPORATE DR. SE DECISION MADE: 03-FEB-11 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE VERTICAL TECHNOLOGY, INC. 510(k) NO: K110045(SPECIAL) ATTN: SURESH GHAI PHONE NO : 952 979 9357 5909 BAKER ROAD, SUITE 550 SE DECISION MADE: 03-FEB-11 MINNESOTA MN 55345 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TURBO TEMP 3 DANVILLE MATERIALS, INC. 510(k) NO: K102753(TRADITIONAL) ATTN: LINDSAY TILTON PHONE NO : 925 973 0710 3420 FOSTORIA WAY, SUITE A-200 SE DECISION MADE: 04-FEB-11 SAN RAMON CA 94583 510(k) STATEMENT DEVICE: BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN BAM CORP., LTD. 510(k) NO: K093835(ABBREVIATED) ATTN: MARY MEJAES PHONE NO : 852 231 41300 UNIT 1706, TOWER 2, GRAND CNTL PLASE DECISION MADE: 04-FEB-11 COMMITTEE RD.,SHATIN, N.T. HK 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOLDEN GATE ANTERIOR PLATE SYSTEM ULRICH GMBH & CO. KG 510(k) NO: K101353(TRADITIONAL) ATTN: HANS STOVER PHONE NO : 636 519 0268 754 SPIRIT 40 PARK DRIVE SE DECISION MADE: 04-FEB-11 CHESTERFIELD MO 63005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVUE COLORMARK9TM) NEEDLE NU VUE THERAPEUTICS, INC 510(k) NO: K101312(TRADITIONAL) ATTN: ROGER S KOLASINSKI PHONE NO : 703 591 1691 11135 SEDGEFIELD ROAD SE DECISION MADE: 04-FEB-11 FAIRFAX VA 22030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D ASTORIA-PACIFIC,INC. 510(k) NO: K101392(TRADITIONAL) ATTN: JASON C REYNOLDS PHONE NO : 503 657 3010 15130 S.E. 82ND DR. SE DECISION MADE: 04-FEB-11 CLACKAMAS OR 97015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100 INTUITIVE SURGICAL, INC. 510(k) NO: K101077(TRADITIONAL) ATTN: KAREN UYESUGI PHONE NO : 408 523 2100 950 KIFER RD. SE DECISION MADE: 04-FEB-11 SUNNYVALE CA 94086 5206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STEREOS WORKSTATION BIOSPACE MED 510(k) NO: K101398(TRADITIONAL) ATTN: JOHN J SMITH PHONE NO : 202 637 3638 555 THIRTEENTH ST. NW SE DECISION MADE: 04-FEB-11 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FETAL DOPPLER JPD-100S SHENZHEN JUMPER MEDICAL EQUIPMENT 510(k) NO: K110124(TRADITIONAL) ATTN: DIANE HONG PHONE NO : 862 164 264467 P.O. BOX 237-023 SE DECISION MADE: 04-FEB-11 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: COHESION BONE CEMENT TEKNIMED, S.A.S. 510(k) NO: K103816(SPECIAL) ATTN: J. D WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD SE DECISION MADE: 04-FEB-11 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 INOVISE MEDICAL, INC. 510(k) NO: K103516(TRADITIONAL) ATTN: EARL ANDERSON PHONE NO : 503 431 3821 8770 SW NIMBUS AVENUE SUITE D SE DECISION MADE: 04-FEB-11 BEAVERTON OR 97008 7196 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTICONSTITUENT CALIBRATOR ABBOT LABORATORIES 510(k) NO: K103403(TRADITIONAL) ATTN: LINDA MORRIS PHONE NO : 972 518 6711 1921 HURD DRIVE SE DECISION MADE: 04-FEB-11 IRVING TX 75038 4396 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR SPACELABS HEALTHCARE LTD. 510(k) NO: K103732(SPECIAL) ATTN: THOMAS KROENKE PHONE NO : 303 956 4232 PO BOX 3018 SE DECISION MADE: 04-FEB-11 NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319 INTUITIVE SURGICAL, INC. 510(k) NO: K101743(TRADITIONAL) ATTN: KAREN UYESUGI PHONE NO : 408 523 2100 950 KIFER RD. SE DECISION MADE: 04-FEB-11 SUNNYVALE CA 94086 5206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM CINCINNATI SUB-ZERO PRODUCTS, INC.510(k) NO: K110104(TRADITIONAL) ATTN: STEVEN J BERKE PHONE NO : 513 772 8810 12011 MOSTELLER RD. SE DECISION MADE: 04-FEB-11 CINCINNATI OH 45241 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE VECTEC 510(k) NO: K103707(TRADITIONAL) ATTN: DIANE MANDELL HORWITZ PHONE NO : 703 307 2921 2995 STEVEN MARTIN DR. SE DECISION MADE: 04-FEB-11 FAIRFAX VA 22031 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOBILE MIM MIM SOFTWARE INC. 510(k) NO: K103785(TRADITIONAL) ATTN: LYNN HANIGAN PHONE NO : 216 455 0600 25200 Chagrin Blvd. Suite 200 SE DECISION MADE: 04-FEB-11 Cleveland OH 44122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MH1 MICROHOLTER RECORDER EXELYS LLC 510(k) NO: K101969(TRADITIONAL) ATTN: NEAL KOLBER PHONE NO : 512 327 9997 1705 S. CAPITAL OF TEXAS HWY SUITESE DECISION MADE: 04-FEB-11 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACIES KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K101842(TRADITIONAL) ATTN: RUSSELL MUNVES PHONE NO : 212 497 8208 140 EAST 45TH ST., 25TH FLOOR TWO SE DECISION MADE: 04-FEB-11 NEW YORK NY 10017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 TECO DIAGNOSTICS 510(k) NO: K101673(TRADITIONAL) ATTN: KC CHEN PHONE NO : 714 163 1111 1268 NORTH LAKEVIEW AVE. SE DECISION MADE: 04-FEB-11 ANAHEIM CA 92807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT BODYSTAT LTD. 510(k) NO: K082255(TRADITIONAL) ATTN: I J. MEEUWSEN PHONE NO : 446 246 29571 PO BOX 50 DOUGLAS ISLE OF MAN SE DECISION MADE: 07-FEB-11 BRITISH ISLES UK IM99 1DQ 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P CODONICS, INC. 510(k) NO: K101439(TRADITIONAL) ATTN: GARY W ENOS PHONE NO : 440 243 1198 17991 ENGLEWOOD DR. SE DECISION MADE: 07-FEB-11 MIDDLEBURG HEIGHTS OH 44130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIOPATCH IZUN PHARMACEUTICALS CORPORATION 510(k) NO: K103054(TRADITIONAL) ATTN: IRVING WIESEN PHONE NO : 212 381 8774 420 LEXINGTON AVENUE SE DECISION MADE: 07-FEB-11 NEW YORK NY 10170 510(k) STATEMENT DEVICE: COROENT INTERLOCK SYSTEM NUVASIVE, INC. 510(k) NO: K102547(TRADITIONAL) ATTN: SHEILA BRUSCHI PHONE NO : 858 320 4515 7475 LUSK BLVD SE DECISION MADE: 07-FEB-11 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 BECKMAN COULTER, INC. 510(k) NO: K103373(TRADITIONAL) ATTN: YVETTE LLOYD PHONE NO : 714 961 3626 250 S. KRAEMER BOULEVARD SE DECISION MADE: 07-FEB-11 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER ANGSTROM MFG., INC. 510(k) NO: K103158(TRADITIONAL) ATTN: CHRIS CARRON PHONE NO : 573 483 3773 6539 U.S. HWY. 61 SE DECISION MADE: 07-FEB-11 BLOOMSDALE MO 63627 510(k) STATEMENT DEVICE: MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT BODYSTAT LTD. 510(k) NO: K082254(TRADITIONAL) ATTN: I. J. MEEUWSEN PHONE NO : 446 246 29571 PO BOX 50 DOUGLAS ISLE OF MAN SE DECISION MADE: 07-FEB-11 BRITISH ISLES UK IM99 1DQ 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITOSS BA BOOST BIOACTIVE BONE GRAFT SUBSTITUTE ORTHOVITA, INC. 510(k) NO: K103173(SPECIAL) ATTN: DEBORAH L JACKSON PHONE NO : 610 407 5210 45 GREAT VALLEY PKWY. SE DECISION MADE: 07-FEB-11 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER COVIDIEN, FORMERLY VALLEYLAB, 510(k) NO: K102470(TRADITIONAL) ATTN: DAVID M HORTON PHONE NO : 303 530 6391 5920 LONGBOW DRIVE SE DECISION MADE: 07-FEB-11 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDEOR MATRIX KENSEY NASH CORP. 510(k) NO: K103787(TRADITIONAL) ATTN: LORI BURNS PHONE NO : 484 713 2186 735 PENNSYLVANIA DRIVE SE DECISION MADE: 07-FEB-11 EXTON PA 19341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT) MICERIUM S.P.A. 510(k) NO: K103474(TRADITIONAL) ATTN: SSA CARLA TAZZER PHONE NO : 39 01 857887840 VIA MARCONI 83 SE DECISION MADE: 07-FEB-11 AVENGO IT 16030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH HAKKI MEDICAL TECHNOLOGIES, INC. 510(k) NO: K101900(TRADITIONAL) ATTN: ANDREW ENDAHL PHONE NO : 407 493 6806 3851 62ND AVE. NORTH SUITE A SE DECISION MADE: 07-FEB-11 PINELLAS PARK FL 33781 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVIGATION MARKER, REFLECTIVE MARKER SPHERES ILUMARK GMBH 510(k) NO: K103192(TRADITIONAL) ATTN: ANDRE WEINGERL PHONE NO : 497 463 995413 GRIESWEG 47 SE DECISION MADE: 07-FEB-11 MUHLHEIM GM 78570 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL ARTHROCARE CORP. 510(k) NO: K110164(SPECIAL) ATTN: VALERIE DEFIESTA-NG PHONE NO : 408 736 0224 680 VAQUEROS AVE. SE DECISION MADE: 07-FEB-11 SUNNYVALE CA 94085 3523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028, VIBRYNT, INC 510(k) NO: K100533(TRADITIONAL) ATTN: JULIA S ANASTAS PHONE NO : 650 362 6136 701-A GALVESTON DRIVE SE DECISION MADE: 08-FEB-11 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM GE HEALTHCARE 510(k) NO: K101236(TRADITIONAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 INNOVATION DRIVE SE DECISION MADE: 08-FEB-11 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEL HEALTH GUIDE INTEL CORPORATION DIGITAL HEALTH G510(k) NO: K103276(ABBREVIATED) ATTN: MAUREEN GYLNN PHONE NO : 916 356 1109 1900 PRAIRIE CITY ROAD FM7-197 SE DECISION MADE: 08-FEB-11 Folsom CA 95630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K110202(TRADITIONAL) ATTN: KATHERINE Y CHOI PHONE NO : 203 602 3568 419 WEST AVE. SE DECISION MADE: 08-FEB-11 STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DEFIBRILLATOR ANALYZER - DA-2006P BC GROUP INTERNATIONAL, INC 510(k) NO: K110192(TRADITIONAL) ATTN: JACK SLOVICK PHONE NO : 763 639 0238 2913 209TH LANE NW SE DECISION MADE: 08-FEB-11 OAK GROVE MN 55011 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K110199(TRADITIONAL) ATTN: ZHAI PEI PHONE NO : 867 552 6582888 MINDRAY BLDG. KEJI 12TH RD S. HI-TSE DECISION MADE: 08-FEB-11 SHENZHEN, GUANGDONG CH 518057 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES LEONHARD LANG GMBH 510(k) NO: K103186(TRADITIONAL) ATTN: ELAINE DUNCAN PHONE NO : 715 549 6035 P.O. BOX 560 SE DECISION MADE: 08-FEB-11 STILLWATER MN 55082 0560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLOWREST VAPOTHERM, INC. 510(k) NO: K103316(TRADITIONAL) ATTN: GREGORY A WHITNEY PHONE NO : 410 604 0808 198 LOG CANOE CIRCLE SE DECISION MADE: 08-FEB-11 STEVENSVILLE MD 21666 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030 JEIL MEDICAL CORPORATION 510(k) NO: K101902(TRADITIONAL) ATTN: CATHY CAMBRIA PHONE NO : 770 396 5909 1733 CANTON LANE SE DECISION MADE: 08-FEB-11 MARIETTA GA 30062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MED-LOK SAFETY NEEDLE STA-MED, LLC 510(k) NO: K103781(SPECIAL) ATTN: RANDALL MAY PHONE NO : 949 209 8969 4932 E. HOLBROOK STREET SE DECISION MADE: 08-FEB-11 ANAHEIM CA 92807 510(k) STATEMENT DEVICE: TRILLIANT SURGICAL SUBTALAR IMPLANT TRILLIANT SURGICAL LTD 510(k) NO: K103183(TRADITIONAL) ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD SE DECISION MADE: 08-FEB-11 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICAL VISORS MV100 MEDICAL VISORS, INC 510(k) NO: K103507(TRADITIONAL) ATTN: BRAIN HUGHES PHONE NO : 818 961 4622 3834 ORCHID LANE SUITE B SE DECISION MADE: 08-FEB-11 CALABASAS CA 91302 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEAL FORCE CO2 INCUBATOR SHANGHAI LISHEN SCIENTIFIC EQUIPME510(k) NO: K101988(TRADITIONAL) ATTN: CHARLES MACK PHONE NO : 541 376 5063 77325 JOYCE WAY SE DECISION MADE: 08-FEB-11 ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE SMITH & NEPHEW, INC. 510(k) NO: K110069(SPECIAL) ATTN: SHEREEN MYERS PHONE NO : 901 399 6325 1450 EAST BROOKS RD. SE DECISION MADE: 08-FEB-11 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEUCADIA PEDICLE SCREW SYSTEM PHYGEN, LLC 510(k) NO: K103102(SPECIAL) ATTN: HARTMUT LOCH PHONE NO : 949 752 7885 2301 DUPONT DRIVE SUITE 510 SE DECISION MADE: 08-FEB-11 IRVINE CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) LANX, LLC 510(k) NO: K103040(SPECIAL) ATTN: DAMON BELLONI PHONE NO : 303 443 7500 390 INTERLOCKEN CRESCENT SUITE 890SE DECISION MADE: 08-FEB-11 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I-STAT 1 WIRELESS ANALYZER ABBOTT POINT OF CARE INC. 510(k) NO: K103195(TRADITIONAL) ATTN: LARRY W KRASLEY PHONE NO : 609 454 9000 400 COLLEGE RD EAST SE DECISION MADE: 08-FEB-11 PRINCETON NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULSE OXIMETER MODEL P10 MEDIANA CO., LTD. 510(k) NO: K100225(TRADITIONAL) ATTN: CHARLIE MACK PHONE NO : 541 376 5063 77325 JOYCE WAY SE DECISION MADE: 09-FEB-11 ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUSE PLIF CAFE ADVANCED MEDICAL TECHNOLOGIES AG 510(k) NO: K100945(TRADITIONAL) ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD. SE DECISION MADE: 09-FEB-11 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYONIZE TM 3JT ENTERPRISES LLC 510(k) NO: K103310(TRADITIONAL) ATTN: ANTHONY GOLDBOSS PHONE NO : 312 952 5462 2000 N. RACINE AVE SUITE 3100 SE DECISION MADE: 09-FEB-11 CHICAGO IL 60614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HAMMERLOC TM TIBIAL FIXATION DEVICE BIOMET SPORTS MEDICINE 510(k) NO: K103145(TRADITIONAL) ATTN: ROBERT FRIDDLE PHONE NO : 574 267 6639 56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 09-FEB-11 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM BLACKROCK MICROSYSTEMS, INC 510(k) NO: K110010(SPECIAL) ATTN: JERRY ALPERIN PHONE NO : 801 582 5533 391 CHIPETA WAY SUITE G SE DECISION MADE: 09-FEB-11 SALT LAKE CITY UT 84108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AAIO-7, AAIO WIRLESS APPASAMY ASSOCIATES 510(k) NO: K110205(TRADITIONAL) ATTN: K RENGASAMY PHONE NO : 910 443 2980153 20, SBI OFFICERS COLONY 1ST STREETSE DECISION MADE: 09-FEB-11 ARUMBAKKAM, CHENNAI IN 600 106 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: EXPLORER LIVER (PASSIVE TRACKING) PATHFINDER THERAPEUTICS, INC. 510(k) NO: K101979(SPECIAL) ATTN: SENHU LI PHONE NO : 615 783 0094 2969 ARMORY DR. SUITE 100A SE DECISION MADE: 09-FEB-11 NASHVILLE TN 37204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP VERSION 2) STERIS CORPORATION 510(k) NO: K102296(TRADITIONAL) ATTN: ROBERT SULLIVAN PHONE NO : 440 392 7695 5960 HEISLEY ROAD SE DECISION MADE: 09-FEB-11 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENUS BASIC SPINAL FIXATION SYSTEM L&K BIOMED CO., LTD 510(k) NO: K103085(SPECIAL) ATTN: HEE KYEONG JOO PHONE NO : 822 262 41471 #1104, ACE HIGH-END TOWER 2CHA, 37SE DECISION MADE: 09-FEB-11 GEUMCHEON-GU, SEOUL KS 153-803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT ESWALLOW USA 510(k) NO: K092202(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO COURT SE DECISION MADE: 10-FEB-11 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLONRING NITI SURGICAL SOLUTIONS LTD 510(k) NO: K093661(TRADITIONAL) ATTN: JONATHAN KAHAN PHONE NO : 202 637 5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 10-FEB-11 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 EXCELSIOR MEDICAL CORP. 510(k) NO: K101270(TRADITIONAL) ATTN: NANCY RUTH PHONE NO : 905 689 3980 4 INNOVATION DRIVE SE DECISION MADE: 10-FEB-11 DUNDAS, ON CA L2H 7P3 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REUSABLE LINEAR STAPLER HANDLE ETHICON ENDO-SURGERY, LLC 510(k) NO: K110049(TRADITIONAL) ATTN: DENNIS HAHN PHONE NO : 513 337 3134 4545 CREEK ROAD SE DECISION MADE: 10-FEB-11 CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REDSENSE-ALARM UNIT AND SENSOR REDSENSE MEDICAL AB 510(k) NO: K103242(TRADITIONAL) ATTN: CONSTANCE G BUNDY PHONE NO : 763 574 1976 435 RICE CREEK TERRANCE SE DECISION MADE: 10-FEB-11 FRIDLEY MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPPHINE PLUS STM 3W DIODE LASER DEN-MAT HOLDINGS, LLC 510(k) NO: K110079(TRADITIONAL) ATTN: ALAN B METTHEWS PHONE NO : 805 922 8491 2727 SKYWAY DR. SE DECISION MADE: 10-FEB-11 SANTA MARIA CA 93455 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VENUS ANTERIOR CERVICAL PLATE VERTICOR, LTD 510(k) NO: K103137(TRADITIONAL) ATTN: J.D. WEBB PHONE NO : 512 399 0199 1001 OAKWOOD BLVD. SE DECISION MADE: 10-FEB-11 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENOFER PUMP RENAL SOLUTIONS, INC. 510(k) NO: K103564(SPECIAL) ATTN: DAVID VANELLA PHONE NO : 724 772 6900 770 COMMONWEALTH DR SUITE 101 SE DECISION MADE: 10-FEB-11 WARRENDALE PA 15086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM ZEUS SCIENTIFIC, INC. 510(k) NO: K102283(TRADITIONAL) ATTN: EWA NADOLCZAK PHONE NO : 908 526 3744 200 EVANS WAY SE DECISION MADE: 10-FEB-11 BRANCHBURG NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PSORIA-LIGHT PSORIA-SHIELD INC. 510(k) NO: K103540(TRADITIONAL) ATTN: WAYNE GLOVER PHONE NO : 813 920 4795 19404 PINE VALLEY DR. SE DECISION MADE: 10-FEB-11 ODESSA FL 33556 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION BIONOSTICS, INC. 510(k) NO: K103553(TRADITIONAL) ATTN: RANDY BYRD PHONE NO : 978 772 7070 7 JACKSON RD. SE DECISION MADE: 10-FEB-11 DEVENS MA 01434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LANX FUSION SYSTEM LANX, LLC 510(k) NO: K102738(TRADITIONAL) ATTN: ALAN BURKHOLDER PHONE NO : 303 443 7500 390 INTERLOCKEN CRESCENT SUITE 890SE DECISION MADE: 10-FEB-11 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASTERSCREEN IOS CAREFUSION GERMANY 234 GMBH 510(k) NO: K101873(TRADITIONAL) ATTN: ELMAR NIEDERMEYER PHONE NO : 499 314 972361 LEIBNIZSTRASSE 7 SE DECISION MADE: 10-FEB-11 HOECHBERG GM 97204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE ABBOTT VASCULAR-CARDIAC THERAPIES 510(k) NO: K103101(TRADITIONAL) ATTN: KAY SETZER PHONE NO : 951 914 3242 26531 YNEZ RD. SE DECISION MADE: 10-FEB-11 TEMECULA CA 92591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. 510(k) NO: K093745(TRADITIONAL) ATTN: LISA MCGRATH PHONE NO : 408 956 4446 1000 GIBRALTAR DR., MS 2C SE DECISION MADE: 11-FEB-11 MILPITAS CA 95035 6312 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS MICROGENICS CORP. 510(k) NO: K100144(TRADITIONAL) ATTN: LISA CHARTER PHONE NO : 510 979 5142 46360 FREMONT BLVD SE DECISION MADE: 11-FEB-11 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROCHE ORAL FLUID COCAINE ROCHE DIAGNOSTICS 510(k) NO: K101160(TRADITIONAL) ATTN: MICHELLE LEE NEFF PHONE NO : 317 521 2000 9115 HAGUE ROAD SE DECISION MADE: 11-FEB-11 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSLOC MINI V3 JMS NORTH AMERICA CORPORATION 510(k) NO: K110157(SPECIAL) ATTN: E. J SMITH PHONE NO : 410 451 0639 1468 HARWELL AVE. SE DECISION MADE: 11-FEB-11 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL BOSTON SCIENTIFIC CORP. 510(k) NO: K102714(TRADITIONAL) ATTN: DEBBIE MCINTIRE PHONE NO : 408 935 4679 ONE SCIMED PLACE SE DECISION MADE: 11-FEB-11 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS MEDTRONIC INC. 510(k) NO: K103386(SPECIAL) ATTN: ANU GAUR PHONE NO : 978 739 3080 35-37A CHERRY HILL DRIVE SE DECISION MADE: 11-FEB-11 DANVERS MA 01923 5186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A ROCHE DIAGNOSTICS 510(k) NO: K093867(TRADITIONAL) ATTN: MICHELLE LEE NEFF PHONE NO : 317 521 2000 9115 HAGUE ROAD SE DECISION MADE: 11-FEB-11 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISUALIZE: VASCULAR THE MEDIPATTERN CORPORATION 510(k) NO: K103761(TRADITIONAL) ATTN: ERIN WALSH PHONE NO : 416 744 0009#250 3080 YOUNGE STREET SUITE 4070 SE DECISION MADE: 11-FEB-11 TORONTO, ON CA M4N 3N1 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS ANTI-TPO CALSET ROCHE DIAGNOSTICS 510(k) NO: K103171(TRADITIONAL) ATTN: SARAH BAUMANN PHONE NO : 317 521 3952 9115 HAGUE ROAD P.O. BOX 50416 SE DECISION MADE: 11-FEB-11 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER EDWARDS LIFESCIENCES LLC 510(k) NO: K110103(SPECIAL) ATTN: SPENCER WALKER PHONE NO : 801 565 6103 12050 LONE PEAK PARKWAY SE DECISION MADE: 11-FEB-11 DRAPER UT 84020 0000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSAFITCUP CC TRIO MEDACTA INTERNATIONAL 510(k) NO: K103352(TRADITIONAL) ATTN: NATALIE J KENNEL PHONE NO : 858 705 0350 13721 VIA TRES VISTA SE DECISION MADE: 11-FEB-11 SAN DIEGO CA 92129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) BREATHE TECHNOLOGIES, INC. 510(k) NO: K103345(TRADITIONAL) ATTN: JOSEPH CIPILLONE PHONE NO : 925 359 1508 4000 EXECUTIVE PARKWAY, SUITE 190 SE DECISION MADE: 11-FEB-11 SAN RAMON CA 94583 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY SHERPA KOREA 510(k) NO: K103346(TRADITIONAL) ATTN: RAYMOND KELLY PHONE NO : 603 595 0095 56B SHADOWBROOK DR SE DECISION MADE: 11-FEB-11 HUDSON NH 03051 510(k) STATEMENT DEVICE: SUPERDIMENSION MARKER DELIVERY KIT SUPERDIMENSION INC. 510(k) NO: K110093(SPECIAL) ATTN: JONATHAN KOVACH PHONE NO : 763 210 4015 161 CHESHIRE LANE NORTH SUITE 100 SE DECISION MADE: 11-FEB-11 MINNEAPOLIS MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4CIS VANE SPINE SYSTEM SOLCO BIOMEDICAL CO., LTD. 510(k) NO: K101818(TRADITIONAL) ATTN: SAEYOUNG AHN PHONE NO : 301 602 4014 9700 GREAT SENECA HWY SUITE 302 SE DECISION MADE: 11-FEB-11 ROCKVILLE MD 20850 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NC TREK RX CORONARY DILATATION CATHETER ABBOTT VASCULAR-CARDIAC THERAPIES 510(k) NO: K110134(SPECIAL) ATTN: SUZANNE REDMAN PHONE NO : 951 914 3243 26531 YNEZ RD. MAILING P.O. BOX 90SE DECISION MADE: 11-FEB-11 TEMECULA CA 92589 9018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRIVO MR355, OPTIMA MR360 GE HANGWEI MEDICAL SYSTEMS CO., LT510(k) NO: K103330(TRADITIONAL) ATTN: RUOQIAN LIU PHONE NO : 861 058 068943 NO.2, YONG CHANG NORTH RD. BEIJINGSE DECISION MADE: 11-FEB-11 BEIJING CH 100176 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM BRIGHT SPINE, INC 510(k) NO: K102449(TRADITIONAL) ATTN: ROBERT SIMONSON PHONE NO : 561 289 9378 799 N.E. 71ST STREET SE DECISION MADE: 11-FEB-11 BOCA RATON FL 33487 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP SAMSUNG MOBILE DISPLAY CO., LTD 510(k) NO: K102321(TRADITIONAL) ATTN: DAVE KIM PHONE NO : 832 623 2099 333 MEADOWLANDS PKWY #303 SE DECISION MADE: 11-FEB-11 SECAUCUS NJ 07094 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1.5T OPTIMA MR430S GE MEDICAL SYSTEMS, LLC 510(k) NO: K103238(TRADITIONAL) ATTN: NORMA LEMAY PHONE NO : 781 262 5581 301 BALLARDVALE STREET SUITE 4 SE DECISION MADE: 11-FEB-11 WILMINGTON MA 01887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: O2-IN-A-BOX, O2-IN-A-BOX GETO2, INC. 510(k) NO: K102750(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 11-FEB-11 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AS3700 ANESTHSIA DELIVERY SYSTEM MINDRAY DS USA, INC. 510(k) NO: K102471(ABBREVIATED) ATTN: RUSSELL OLSEN PHONE NO : 201 995 8391 800 MACARTHUR BLVD SE DECISION MADE: 11-FEB-11 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMART READ BIOLOGICAL TEST PACK STERITEC PRODUCTS MFG. CO., INC. 510(k) NO: K103000(SPECIAL) ATTN: SUZANNE DENNIS PHONE NO : 303 660 4201 74 INVERNESS DRIVE EAST SE DECISION MADE: 11-FEB-11 ENGLEWOOD CO 80112 510(k) STATEMENT DEVICE: FUSTAR STEERABLE INTRODUCERS LIFETECH SCIENTIFIC (SHENZHEN) CO.510(k) NO: K100184(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 216 4684973 # 19, LN 999, ZHONGSHAN RD S2 SUITSE DECISION MADE: 14-FEB-11 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TELIO CS INLAY & TELIO CS ONLAY IVOCLAR VIVADENT, INC. 510(k) NO: K103379(TRADITIONAL) ATTN: DONNA M HARTNETT PHONE NO : 716 691 0010 175 PINEVIEW DR. SE DECISION MADE: 14-FEB-11 AMHERST NY 14228 510(k) STATEMENT DEVICE: QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION DENTSPLY INTL., INC. 510(k) NO: K103244(TRADITIONAL) ATTN: HELEN LEWIS PHONE NO : 717 845 7511 SUSQUEHANNA COMMERCE CENTER 221 W SE DECISION MADE: 14-FEB-11 YORK PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM A JOHNSON & JOHNSON COMPANY 510(k) NO: K103491(SPECIAL) ATTN: FRANK S JURCZAK PHONE NO : 508 828 3288 325 PARAMOUNT DRIVE SE DECISION MADE: 14-FEB-11 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISA HBA1C, MODEL K3105A SIEMENS HEATLHCARE DIAGNOSTICS INC510(k) NO: K102045(TRADITIONAL) ATTN: ANNA-MARIE K ENNIS PHONE NO : 302 631 9352 500 GBC DRIVE P.O. BOX 6101 SE DECISION MADE: 14-FEB-11 NEWARK DE 19714 6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEODENT GRAFT SCREW JJGC INDUSTRIA E COMERCIO DE MATER510(k) NO: K103084(TRADITIONAL) ATTN: DAVID J COLLETTE PHONE NO : 858 792 1235 11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 14-FEB-11 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE SURGICRAFT LTD. 510(k) NO: K091207(TRADITIONAL) ATTN: DONALD W GUTHNER PHONE NO : 646 460 2984 111 HILL ROAD SE DECISION MADE: 15-FEB-11 DOUGLASSVILLE PA 19518 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFINION ANALYZER AXIS-SHIELD POC AS 510(k) NO: K110056(TRADITIONAL) ATTN: KARI SKINNEMOEN PHONE NO : 472 405 6000 P.O. BOX 6863 RODELOKKA SE DECISION MADE: 15-FEB-11 OSLO NO N-0504 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRIUM CENTRILFX MESH ATRIUM MEDICAL CORPORATION 510(k) NO: K110110(SPECIAL) ATTN: RAYMOND J KELLY PHONE NO : 603 880 1433 5 WENTWORTH DR SE DECISION MADE: 15-FEB-11 HUDSON NH 03051 510(k) STATEMENT DEVICE: ADVANCED MEMBRANE GAS EXCHANGE ("AMG"), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012 EUROSETS S.R.L. 510(k) NO: K102109(TRADITIONAL) ATTN: MARIO GENMARI PHONE NO : 003 905 3552161 VIA G. PUCCINI, 1 SE DECISION MADE: 15-FEB-11 MEDOLLA, MODENA IT I-43036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K103753(TRADITIONAL) ATTN: FRITZ KOLLE PHONE NO : 496 251 163294 FABRIKSTRASSE 31 SE DECISION MADE: 15-FEB-11 BENSHEIM GM D-64625 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS HOWMEDICA OSTEONICS CORP DBA STRYK510(k) NO: K110176(SPECIAL) ATTN: ANTHONY DENNIS PHONE NO : 201 831 5804 325 CORPORATE DRIVE SE DECISION MADE: 15-FEB-11 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PSL ANTERIOR CERVICAL PLATE SYSTEM PRECISION SURGERY LTD. 510(k) NO: K103819(TRADITIONAL) ATTN: KAREN E WARDEN PHONE NO : 440 729 8457 8202 SHERMAN ROAD SE DECISION MADE: 15-FEB-11 CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM PRECISION SURGERY LTD. 510(k) NO: K103838(TRADITIONAL) ATTN: KAREN E WARDEN, PHD. PHONE NO : 440 729 8457 8202 SHERMAN ROAD SE DECISION MADE: 15-FEB-11 CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FINESS ENDOSCOPE ENTELLUS MEDICAL, INC. 510(k) NO: K102366(TRADITIONAL) ATTN: KAREN E PETERSON PHONE NO : 763 463 7056 6705 WEDGWOOD COURT NORTH SE DECISION MADE: 15-FEB-11 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANTAGE ABI SUMMIT DOPPLER SYSTEMS, INC. 510(k) NO: K103693(TRADITIONAL) ATTN: KEN JARRELL PHONE NO : 303 423 7572 4680 TABLE MOUNTAIN DR #150 SE DECISION MADE: 15-FEB-11 GOLDEN CO 80403 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ARM AUTOMATIC BLOOD PRESSURE METER, MODELS FT-C21Y, FT-C22Y, FT-C23Y, FT-C24Y, FT-C11B, FT-C12B, FT-C21Y-V, FT-C22Y-V FUDAKANG INDUSTRIAL CO LTD 510(k) NO: K110281(TRADITIONAL) ATTN: SABRINA WEI PHONE NO : 86 755 83089699 ZHONGFANG JIN YUAN BLDG XINWEN ROASE DECISION MADE: 15-FEB-11 SHENZHEN, GUANGDONG CH 518034 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PHILIPS ECG LEADWIRE SET PHILIPS MEDICAL SYSTEMS 510(k) NO: K110287(ABBREVIATED) ATTN: PETER SCHIPELLITI PHONE NO : 978 659 4744 3000 MINUTEMAN RD. SE DECISION MADE: 15-FEB-11 ANDOVER MA 01810 1099 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TRABECULAR METAL FEMORAL CONE AUGMENTS ZIMMER TRABECULAR METAL TECHNOLOGY510(k) NO: K103517(TRADITIONAL) ATTN: JUDITH ROSEN PHONE NO : 973 576 0032 10 POMEROY RD. SE DECISION MADE: 15-FEB-11 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR ORTHOCON, INC. 510(k) NO: K102762(TRADITIONAL) ATTN: BRIAN KUNST PHONE NO : 914 357 2600 1 BRIDGE STREET, SUITE 121 SE DECISION MADE: 15-FEB-11 IRVINGTON NY 10533 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSTEMS INTEGRATION OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K102763(SPECIAL) ATTN: STACY ABBATIELLO PHONE NO : 484 896 5405 3500 CORPORATE PARKWAY SE DECISION MADE: 15-FEB-11 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENZYME II CALIBRATOR SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K103836(TRADITIONAL) ATTN: ANNA MARIE KATH ENNIS PHONE NO : 302 631 9352 500 GBC DRIVE P.O. BOX 6101 SE DECISION MADE: 16-FEB-11 NEWARK DE 19714 6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZENOSTAR MAGIC GLAZE WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K103494(TRADITIONAL) ATTN: GERHARD POLZER PHONE NO : 490 723 13705219 SCHWENNINGER STRABE 13 SE DECISION MADE: 16-FEB-11 PFORZHEIM GM D-75179 510(k) STATEMENT DEVICE: GDC 360 DETEACHABLE COIL BOSTON SCIENTIFIC CORP. 510(k) NO: K103355(TRADITIONAL) ATTN: RHODA M SANTOS PHONE NO : 510 624 1262 47900 BAYSIDE PARKWAY SE DECISION MADE: 16-FEB-11 FREMONT CA 94538 6515 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O CONMED CORPORATION 510(k) NO: K103665(TRADITIONAL) ATTN: SHAWN RIEDEL PHONE NO : 303 269 8224 14603 E. FREMONT AVE. SE DECISION MADE: 16-FEB-11 CENTENNIAL CO 80112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE ARTHROCARE CORP. 510(k) NO: K110183(SPECIAL) ATTN: VALERIE DEFIESTA-NG PHONE NO : 408 736 0224 680 VAQUEROS AVE. SE DECISION MADE: 16-FEB-11 SUNNYVALE CA 94085 3523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES DANA PRODUCTS, INC. 510(k) NO: K103321(TRADITIONAL) ATTN: HARRY BALA PHONE NO : 847 455 2881 7 COREY DR. SE DECISION MADE: 16-FEB-11 SOUTH BARRINGTON IL 60010 510(k) STATEMENT DEVICE: CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K103678(TRADITIONAL) ATTN: ALBRECHT MALKMUS PHONE NO : 497 614 543481 MUNZINGER STRASSE 5 SE DECISION MADE: 16-FEB-11 FREIBURG,BADEN WURTTEMBERG GM 7510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNAREX ULTRASOUND GEL DYNAREX CORPORATION 510(k) NO: K102637(TRADITIONAL) ATTN: DANIEL CONSAGA PHONE NO : 845 365 8200 10 GLENSHAW ST. SE DECISION MADE: 16-FEB-11 ORANGEBURG NY 10962 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TECO DIAGNOSTICS UTI DETECTION STRIPS TECO DIAGNOSTICS 510(k) NO: K100024(TRADITIONAL) ATTN: KC CHEN PHONE NO : 714 225 9979 1268 NORTH LAKEVIEW AVE. SE DECISION MADE: 17-FEB-11 ANAHEIM CA 92807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD. 510(k) NO: K110207(TRADITIONAL) ATTN: RICHARD CEHOVSKY PHONE NO : 800 872 5652 10 FAIRFIELD BLVD. SE DECISION MADE: 17-FEB-11 WALLINGFORD CT 06492 7502 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K110168(SPECIAL) ATTN: EILEEN M BOYLE PHONE NO : 978 421 9171 269 MILL ROAD SE DECISION MADE: 17-FEB-11 CHELMSFORD MA 01824 4105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEL-CYPHER N TAKARA BELMONT CORPORATION 510(k) NO: K110160(SPECIAL) ATTN: KUNIHIKO SOBUE PHONE NO : 732 469 5000 101 BELMONT DR SE DECISION MADE: 17-FEB-11 SOMERSET NJ 08873 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOLIFE NASAL MASK RESPIRONICS, INC. 510(k) NO: K110008(SPECIAL) ATTN: MICHELLE BRINKER PHONE NO : 724 387 4146 365 PLUM INDUSTRIAL COURT SE DECISION MADE: 17-FEB-11 PITTSBURGH PA 15239 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM SPARTEK MEDICAL, INC. 510(k) NO: K103383(SPECIAL) ATTN: HENRY KLYCE PHONE NO : 510 545 4899 1100 MARINA VILLIAGE PKWY SUITE 10SE DECISION MADE: 17-FEB-11 ALAMEDA CA 94501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLARITY ADVANCED CERAMIC BRACKETS 3M UNITEK CORPORATION 510(k) NO: K102803(TRADITIONAL) ATTN: MARLYN L SCHEFF PHONE NO : 626 574 4496 2724 SOUTH PECK RD. SE DECISION MADE: 17-FEB-11 MONROVIA CA 91016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM JOHNSON & JOHNSON 510(k) NO: K103490(TRADITIONAL) ATTN: KEVIN STEVENS PHONE NO : 508 977 6445 325 PARAMOUNT DR. SE DECISION MADE: 17-FEB-11 RAYNHAM MA 02767 0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G-SCAN ESAOTE S.P.A. 510(k) NO: K110238(SPECIAL) ATTN: ALLISON SCOTT PHONE NO : 317 569 9500 11460 N MERIDIAN STREET SUITE 150 SE DECISION MADE: 17-FEB-11 CARMEL IN 46032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR ENDYMED MEDICAL LTD 510(k) NO: K101510(TRADITIONAL) ATTN: YORAM LEVY PHONE NO : 972 463 88837 31 HAAVODA ST. SE DECISION MADE: 17-FEB-11 BINYAMINA IS 30500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FILMARRAY RESPIRATORY PANEL (RP) IDAHO TECHNOLOGY, INC. 510(k) NO: K103175(TRADITIONAL) ATTN: BETH LINGENFELTER PHONE NO : 801 736 6354 390 WAKARA WAY SE DECISION MADE: 17-FEB-11 SALT LAKE CITY UT 84108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K110154(SPECIAL) ATTN: EILEEN M BOYLE PHONE NO : 978 421 9171 269 MILL ROAD SE DECISION MADE: 17-FEB-11 CHELMSFORD MA 01824 4105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STIMTRODE SINGLE USE NERVE STIMULATOR XAVANT TECHNOLOGY (PTY), LTD. 510(k) NO: K110118(SPECIAL) ATTN: BRIAN ROTHMAN PHONE NO : 271 275 59491 169 GARSFONTEIN ROAD ASHLEA GARDENSE DECISION MADE: 17-FEB-11 PRETORIA, GAUTENG SF 0081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IVOBASE HYBRID, IVOBASE HIGH IMPACT IVOCLAR VIVADENT, INC. 510(k) NO: K103391(TRADITIONAL) ATTN: DONNA HARTNETT PHONE NO : 716 691 2260 175 PINEVIEW DR. SE DECISION MADE: 17-FEB-11 AMHERST NY 14228 510(k) STATEMENT DEVICE: MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153 CONCENTRIC MEDICAL, INC. 510(k) NO: K093610(TRADITIONAL) ATTN: KIRSTEN VALLEY PHONE NO : 650 810 1707 301 E. EVELYN AVE. SE DECISION MADE: 17-FEB-11 MOUNTAIN VIEW CA 94041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 30W PRO IR LAMP SYSTEM, NEXUS USA LASER BIOTECH INC. 510(k) NO: K101893(TRADITIONAL) ATTN: M. JOYCE HEINRICH PHONE NO : 713 734 4433 12101 CULLEN BOULEVARD # A SE DECISION MADE: 17-FEB-11 HOUSTON TX 77047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROCKWOOD CLAVICLE PINS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K103001(TRADITIONAL) ATTN: SUZANNA OTANO PHONE NO : 305 269 6386 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 17-FEB-11 WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FASTPACK TESTO IMMUNOASSAY QUALIGEN, INC. 510(k) NO: K101388(SPECIAL) ATTN: MICHAEL S POIRIER PHONE NO : 760 918 9165 2042 CORTE DEL NOGAL SUITE B SE DECISION MADE: 18-FEB-11 CARLSBAD CA 92011 1438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFE'N'SOUND PASSIVE DELIVERY SYSTEM REXAM PHARMA 510(k) NO: K101233(ABBREVIATED) ATTN: JEFFREY BURRIS PHONE NO : 317 346 5178 600 DEERFIELD PKWY SE DECISION MADE: 18-FEB-11 BUFFALO GROVE IL 60089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) EDWARDS LIFESCIENCES, LLC. 510(k) NO: K110167(SPECIAL) ATTN: MARGUERITE THOMLINSON PHONE NO : 949 756 4386 ONE EDWARDS WAY SE DECISION MADE: 18-FEB-11 IRVINE CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH CO., LTD. 510(k) NO: K102259(TRADITIONAL) ATTN: DAVE KIM PHONE NO : 832 623 2099 333 MEADOWLANDS PARKWAY, #303 SE DECISION MADE: 18-FEB-11 SECAUCUS NJ 07094 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUIBAND DUAL, MODEL LBD 001 MEDLOGIC GLOBAL LIMITED 510(k) NO: K102076(TRADITIONAL) ATTN: MICHAEL BROWNE PHONE NO : 441 752 209955 WESTERN WOOD WAY LANGAGE SCIENCE PSE DECISION MADE: 18-FEB-11 PLYMOUTH, DEVON UK PL7 5BG 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET VAOSNOVA, INCORPORATED 510(k) NO: K103255(TRADITIONAL) ATTN: KIM TOMPKINS, RN, MBA PHONE NO : 650 388 5600 155 JEFFERSON DRIVE SUITE 100 SE DECISION MADE: 18-FEB-11 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINITY CNAP SMARTPOD DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K102968(TRADITIONAL) ATTN: JOYCE KILROY PHONE NO : 267 885 9989 6 TECH DRIVE SE DECISION MADE: 18-FEB-11 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE VAOSNOVA, INCORPORATED 510(k) NO: K103260(TRADITIONAL) ATTN: KIM TOMPKINS PHONE NO : 650 388 5600 155 JEFFERSON DRIVE SUITE 100 SE DECISION MADE: 18-FEB-11 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED PULSE OXIMETER SENSORS STERILMED, INC. 510(k) NO: K102560(TRADITIONAL) ATTN: GARRETT AHLBORG PHONE NO : 763 488 3483 11400 73RD AVE. N, STE. 100 SE DECISION MADE: 18-FEB-11 MAPLE GROVE MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILIZATION MATS STERIS CORPORATION 510(k) NO: K103226(TRADITIONAL) ATTN: ROBERT F SULLIVAN PHONE NO : 440 392 7695 5960 HEISLEY ROAD SE DECISION MADE: 18-FEB-11 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STEMPRO MSC SFM LIFE TECHNOLOGIES CORPORATION 510(k) NO: K103302(TRADITIONAL) ATTN: KELLI TANZELLA PHONE NO : 716 774 3122 3175 STALEY ROAD SE DECISION MADE: 18-FEB-11 GRAND ISLAND NY 14072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD 510(k) NO: K110330(SPECIAL) ATTN: LIU YI PHONE NO : 862 260 526161 NO 3, JINPING STREET YA AN RD NANSE DECISION MADE: 18-FEB-11 TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K103701(ABBREVIATED) ATTN: KIRA GORDON PHONE NO : 914 524 2996 511 BENEDICT AVE SE DECISION MADE: 18-FEB-11 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT EXAMINATION GLOES THAI HUA HOLDING CO., LTD. 510(k) NO: K102840(TRADITIONAL) ATTN: KOK-KEE HON PHONE NO : 703 941 7656 6324 MEETINGHOUSE WAY SE DECISION MADE: 18-FEB-11 ALEXANDRIA VA 22312 1718 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X2ABS DUAL CHANNEL FITNESS BELT LETO ENTERPRISES INCORPORATION 510(k) NO: K102295(TRADITIONAL) ATTN: SABRINA WEI PHONE NO : 867 558 3089699 19/F, NAN DAO COMMERCIAL BLDG, QUESE DECISION MADE: 18-FEB-11 HONG KONG CH 999077 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM DELTAMED GMBH 510(k) NO: K102776(TRADITIONAL) ATTN: EMANUEL MESARIC PHONE NO : 011 49 603172830 RAIFFEISENSTR. 8A SE DECISION MADE: 18-FEB-11 FRIEDBERG GM D-61169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 MORTARA INSTRUMENT, INC. 510(k) NO: K102206(ABBREVIATED) ATTN: CHARLES MORREALE PHONE NO : 414 354 1600 7865 NORTH 86TH ST. SE DECISION MADE: 18-FEB-11 MILWAUKEE WI 53224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VTS1000 VUETEK SCIENTIFIC LLC 510(k) NO: K101838(TRADITIONAL) ATTN: PAUL SUMNER PHONE NO : 770 448 7529 1733 CANTON LANE SUITE B SE DECISION MADE: 18-FEB-11 MARIETTA GA 30062 2679 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES SCOUT VESSEL GUARD SYNTHES SPINE 510(k) NO: K103558(TRADITIONAL) ATTN: HEATHER GUERIN PHONE NO : 610 719 5712 1302 WRIGHTS LANE EAST SE DECISION MADE: 18-FEB-11 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM CODMAN & SHURTLEFF, INC. 510(k) NO: K102961(SPECIAL) ATTN: JOCELYN RAPOSO PHONE NO : 508 828 3421 325 PARAMOUNT DR. SE DECISION MADE: 18-FEB-11 RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIM 5.2 (BRACHY) MIM SOFTWARE INC. 510(k) NO: K103576(TRADITIONAL) ATTN: LYNN HANIGAN PHONE NO : 216 455 0600 25200 Chagrin Blvd. Suite 200 SE DECISION MADE: 18-FEB-11 Cleveland OH 44122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY DERMA SCIENCES, INC. 510(k) NO: K101793(TRADITIONAL) ATTN: RONALD S WARREN PHONE NO : 858 753 1961 49 PLAIN STREET SE DECISION MADE: 22-FEB-11 NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN ENVITEC-WISMAR GMBH 510(k) NO: K102270(TRADITIONAL) ATTN: STEPHEN GORSKI PHONE NO : 262 594 2114 S65 W35739 PIPER ROAD SE DECISION MADE: 22-FEB-11 EAGLE WI 53119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ML24000 UVA-1 PHOTOTHERAPY UNIT THE DAAVLIN DISTRIBUTING COMPANY 510(k) NO: K103708(TRADITIONAL) ATTN: MICHAEL THIEL PHONE NO : 419 636 6304 205 WEST BEMENT STREET SE DECISION MADE: 22-FEB-11 BRYAN OH 43506 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION WAKO CHEMICALS USA, INC. 510(k) NO: K100464(TRADITIONAL) ATTN: MARTHA MURARI PHONE NO : 650 210 9153 1025 TERRA BELLA AVE SUITE A SE DECISION MADE: 23-FEB-11 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS BIOMET, INC. 510(k) NO: K102125(TRADITIONAL) ATTN: GARY BAKER, MS, RAC PHONE NO : 574 267 6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 23-FEB-11 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNAFLEX DYNAFLEX 510(k) NO: K103076(TRADITIONAL) ATTN: STUART R GOLDMAN PHONE NO : 512 327 9997 611 WEST 5TH STREET THIRD FLOOR SE DECISION MADE: 23-FEB-11 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE JJGC INDUSTRIA E COMERCIO DE MATER510(k) NO: K102769(TRADITIONAL) ATTN: DAVID COLLETTE PHONE NO : 858 792 1235 11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 23-FEB-11 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCOM CLINICALCONNEX CARDIOMAX ASCOM (US), INC. 510(k) NO: K103634(TRADITIONAL) ATTN: THOMAS KROENKE PHONE NO : 303 956 4232 PO BOX 3018 SE DECISION MADE: 23-FEB-11 NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K103264(TRADITIONAL) ATTN: STACY ABBATIELL KLUESNER, MPHONE NO : 484 896 5405 3500 CORPORATE PARKWAY PO BOX 610 SE DECISION MADE: 23-FEB-11 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INDISCAL DIGITAL MANOMETER BAYLIS MEDICAL CO., INC. 510(k) NO: K102192(TRADITIONAL) ATTN: MEGHAL KHAKHAR PHONE NO : 905 602 4875 2645 MATHESON BLVD. E SE DECISION MADE: 23-FEB-11 MISSISSAUGA, ONTARIO CA L4W 5S4510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIDEK MULTICOLOR LASER PHOTOCOAGULATOR NIDEK INCORPORATED 510(k) NO: K110228(SPECIAL) ATTN: KIT CARIQUITAN PHONE NO : 408 400 0856 155-A MOFFETT PARK DRIVE SUITE 210SE DECISION MADE: 23-FEB-11 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBONY PTA .035 PERIPHERAL DILATATION CATHETER NATEC MEDICAL LTD 510(k) NO: K103354(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 888 729 9674 1468 HARWELL AVENUE SE DECISION MADE: 23-FEB-11 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V-GO INSULIN DELIVERY SYSTEM VALERITAS, INC. 510(k) NO: K103825(TRADITIONAL) ATTN: SCOTT HUIE PHONE NO : 508 845 1177 800 BOSTON TURNPIKE SE DECISION MADE: 23-FEB-11 SHREWSBURY MA 01545 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931 ANDON HEALTH CO.,LTD 510(k) NO: K102939(SPECIAL) ATTN: LIU YI PHONE NO : 862 260 526161 NO 3, JINPING STREET YA AN RD NANSE DECISION MADE: 23-FEB-11 TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASTRA TECH IMPLANT SYSTEM ASTRA TECH AB 510(k) NO: K101732(TRADITIONAL) ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235 11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 23-FEB-11 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, CADWELL LAB, INC. 510(k) NO: K103128(TRADITIONAL) ATTN: CHRIS L BOLKAN PHONE NO : 509 735 6481 909 NORTH KELLOGG ST. SE DECISION MADE: 23-FEB-11 KENNEWICK WA 99336 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK MICROTEK MEDICAL, INC. 510(k) NO: K102971(TRADITIONAL) ATTN: THOMAS B BONNER, JR. PHONE NO : 888 844 0988 602 LEHMBERG RD. SE DECISION MADE: 23-FEB-11 COLUMBUS MS 39702 510(k) STATEMENT DEVICE: SPECTRASHIELD 9500 SURGICAL MASK NEXERA MEDICAL, INC 510(k) NO: K090414(TRADITIONAL) ATTN: PAUL SALLARULO PHONE NO : 954 495 2031 1556 EAST COMMERCIAL BLVD. SE DECISION MADE: 24-FEB-11 OAKLAND PARK FL 33334 5752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT SAFE LUER CAP RETRACTABLE TECHNOLOGIES, INC. 510(k) NO: K101708(TRADITIONAL) ATTN: RHONDA WELLS PHONE NO : 972 294 1010 511 LOBO LN. SE DECISION MADE: 24-FEB-11 LITTLE ELM TX 75068 0009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BHDENTAL IMPLANT SYSTEM BHDENTAL LTD 510(k) NO: K103280(TRADITIONAL) ATTN: EILAT EZRA PHONE NO : 972 542 422555 21 HANAFA STREET SE DECISION MADE: 24-FEB-11 ZUR-MOSHE IS 42810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILS PORT COVIDEN (FORMERLY REGISTERED AS US510(k) NO: K103253(TRADITIONAL) ATTN: TIM M LOHNES PHONE NO : 203 492 5462 60 MIDDLETOWN AVE. SE DECISION MADE: 24-FEB-11 NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM BIOLITEC, INC. 510(k) NO: K110080(TRADITIONAL) ATTN: NANCY FOLEY PHONE NO : 413 525 0600 515 SHAKER RD. SE DECISION MADE: 24-FEB-11 EAST LONGMEADOW MA 01028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F ST. JUDE MEDICAL SYSTEMS AB 510(k) NO: K110193(SPECIAL) ATTN: KATRIN SVENSSON PHONE NO : 46 18 161000 PALMBLADSGATAN 10 SE DECISION MADE: 24-FEB-11 UPPSALA SW SE-751 35 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICCOLO COMPOSITE PLATE SYSTEM N.M.B. MEDICAL APPLICATIONS, LTD. 510(k) NO: K102597(TRADITIONAL) ATTN: HILA WACHSLER-AVRAHAMI PHONE NO : 972 995 11511 11 HA'HOSHLIM STREET SE DECISION MADE: 24-FEB-11 HERZELIYA IS 46724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 MERIDIAN BIOSCIENCE, INC. 510(k) NO: K110012(TRADITIONAL) ATTN: MICHELLE L SMITH PHONE NO : 513 271 3700 3471 RIVER HILLS DR. SE DECISION MADE: 24-FEB-11 CINCINNATI OH 45244 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TROPHON NANOSONICS LIMITED 510(k) NO: K103059(TRADITIONAL) ATTN: RON WEINBERGER PHONE NO : 612 806 31600 24/566 GARDENERS ROAD SE DECISION MADE: 24-FEB-11 ALEXANDRIA, NSW AS 2015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM SHOULDER OPTIONS, INC. 510(k) NO: K102539(TRADITIONAL) ATTN: JOHN KAPITAN PHONE NO : 704 843 7852 100 E. SOUTH MAIN ST. P.O. BOX 145SE DECISION MADE: 24-FEB-11 WAXHAW NC 28173 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACPLUS SUCTION UNIT APEX MEDICAL CORP. 510(k) NO: K103535(TRADITIONAL) ATTN: PHONE NO : NO.8, LANE 29, WENMING RD. SE DECISION MADE: 24-FEB-11 GUISAN, TAOYUAN TW 33383 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BILLY BOY MALE LATEX CONDOM SHEILA PICKERING PH.D. 510(k) NO: K103119(TRADITIONAL) ATTN: SHEILA W PICKERING PHONE NO : 650 279 0668 2061 LONGDEN CIRCLE SE DECISION MADE: 24-FEB-11 LOS ALTOS CA 94024 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T COVIDIEN, FORMERLY VALLEYLAB, A DI510(k) NO: K101797(TRADITIONAL) ATTN: DAVID M HORTON PHONE NO : 303 530 6391 5920 LONGBOW DRIVE SE DECISION MADE: 24-FEB-11 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINGLE USE BILIARY DRAINAGE STENT V OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K103478(TRADITIONAL) ATTN: STACY ABBATIELLO KLUESNER PHONE NO : 484 896 5405 3500 CORPORATE PARKWAY PO BOX 610 SE DECISION MADE: 24-FEB-11 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROCHE FLUDI METHAMPHETAMINE ROCHE DIAGNOSTICS 510(k) NO: K093884(TRADITIONAL) ATTN: MICHELLE LEE NEFF PHONE NO : 317 521 2000 9115 HAGUE ROAD SE DECISION MADE: 25-FEB-11 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 CONTRACT MEDICAL INTL. GMBH 510(k) NO: K100799(TRADITIONAL) ATTN: JAN KLOBOUCNIK PHONE NO : 420 494 949564 ZUR WETTERWARTE 50 SE DECISION MADE: 25-FEB-11 DRESDEN, SACHSEN GM 01109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADAPT, MODEL AX-03SN APELIOTUS VISION SCIENCE, INC 510(k) NO: K100954(TRADITIONAL) ATTN: JOHN G EDWARDS PHONE NO : 404 875 9561 1456 N. MORNINGSIDE DRIVE, NE SE DECISION MADE: 25-FEB-11 ATLANTA GA 30306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SNORE GUARD RANIR LLC 510(k) NO: K103004(SPECIAL) ATTN: GERARD J PRUD'HOMME PHONE NO : 202 637 5735 555 THIRTEENTH STREET, NW SE DECISION MADE: 25-FEB-11 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APPROACH PRO ST WIRE GUIDE COOK INCORPORATED 510(k) NO: K110163(SPECIAL) ATTN: AARON SANTNER PHONE NO : 812 339 2235 750 DANIELS WAY SE DECISION MADE: 25-FEB-11 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHELON RAPID CARDIAC COIL HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K110120(ABBREVIATED) ATTN: DOUG THISTLETHWAITE PHONE NO : 330 425 1313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 25-FEB-11 TWINSBURG OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHALLENGE-EVER HALLIM DENTECH CO., LTD. 510(k) NO: K102223(TRADITIONAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 844 2612 2341 W. CRESCENT AVE. SUITE 3 SE DECISION MADE: 25-FEB-11 ANAHEIM CA 92801 510(k) STATEMENT DEVICE: FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM OSTIAL CORPORATION 510(k) NO: K102482(TRADITIONAL) ATTN: ERIC ANKERUD, JD PHONE NO : 650 903 9100 510 CLYDE AVENUE SE DECISION MADE: 25-FEB-11 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIPLE NAME IDEAL QUALITY SDN., BHD. 510(k) NO: K103337(TRADITIONAL) ATTN: SH TAN PHONE NO : 603 329 10516 LOT 2796, 17 1/2 MILES JALAN KAPARSE DECISION MADE: 25-FEB-11 KLANG MY 42200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOSHIBA 1.5T EXTRA LARGE KNEE COIL QUALITY ELECTRODYNAMICS 510(k) NO: K103185(TRADITIONAL) ATTN: CHRISTIE ZYDYK PHONE NO : 440 484 2228 700 BETA DR. SUITE 100 SE DECISION MADE: 25-FEB-11 MAYFIELD VILLAGE OH 44143 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ENDOLOGIX GUIDEWIRE TECHDEVICE CORPORATION 510(k) NO: K110241(SPECIAL) ATTN: GARY BUNNEWITH PHONE NO : 617 972 5810 650 PLEASANT ST. SE DECISION MADE: 25-FEB-11 WATERTOWN MA 02472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERRAAD 100NX EXPRESS CYCLE TEST PACK ADVANCED STERILIZATION PRODUCTS 510(k) NO: K092755(TRADITIONAL) ATTN: NANCY CHU PHONE NO : 949 453 9435 33 TECHNOLOGY DR. SE DECISION MADE: 25-FEB-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERRAD CYCLESURE BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS 510(k) NO: K103222(TRADITIONAL) ATTN: YOGI SHAH PHONE NO : 949 789 8548 33 TECHNOLOGY DR. SE DECISION MADE: 25-FEB-11 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING MAQUET CARDIOPULMONARY AG 510(k) NO: K102532(TRADITIONAL) ATTN: INGRID RICHTER PHONE NO : 011 497 478921337 HECHINGER STRASSE 38 SE DECISION MADE: 25-FEB-11 HIRRLINGEN GM 72145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. 510(k) NO: K103397(TRADITIONAL) ATTN: KYEONG-MI PARK PHONE NO : 822 219 41373 1003 DAECHI-DONG GANGNAM-GU SE DECISION MADE: 25-FEB-11 SEOUL KS 135-280 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS RIVERPOINT MEDICAL 510(k) NO: K103449(ABBREVIATED) ATTN: DOUG ROWLEY PHONE NO : 503 517 8001 825 NE 25TH AVE. SE DECISION MADE: 25-FEB-11 PORTLAND OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-CONTACT INFRARED THERMOMETER K-JUMP HEALTH CO., LTD. 510(k) NO: K102947(TRADITIONAL) ATTN: JASON CHENG PHONE NO : 886 222 991378 NO. 56, WU KUNG 5TH RD., WU KU INDSE DECISION MADE: 25-FEB-11 TAIPEI HSIEN TW 248 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPS EMPRESS DIRECT FLOW IVOCLAR VIVADENT, INC. 510(k) NO: K103528(TRADITIONAL) ATTN: DONNA HARTNETT PHONE NO : 716 691 0010 175 PINEVIEW DR. SE DECISION MADE: 25-FEB-11 AMHERST NY 14228 510(k) STATEMENT DEVICE: VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE) ADVANCED MEDICAL DEVICES FACTORY 510(k) NO: K103772(TRADITIONAL) ATTN: XINGYUAN WANG PHONE NO : 865 362 197038 NO. 8-1 XING'AN ROAD EAST LINQU SE DECISION MADE: 25-FEB-11 WEIFANG, SHANDONG CH 262600 510(k) STATEMENT DEVICE: ESCOM 100 SPIDENT CO., LTD. 510(k) NO: K110428(TRADITIONAL) ATTN: JE MO AHN PHONE NO : 823 281 94570 KOREA INDUSTRIAL COMPLEX 722 KOJANSE DECISION MADE: 25-FEB-11 INCHEON KS 405-821 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LUCIA MERIDIAN CO., LTD. 510(k) NO: K102375(TRADITIONAL) ATTN: VINOD PODICHETTY PHONE NO : 954 559 4213 3550 SW 148 AVENUE SUITE 110 SE DECISION MADE: 25-FEB-11 MIRAMAR FL 33027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENERAL DENISTRY MOTOR ASEPTICO, INC. 510(k) NO: K103399(TRADITIONAL) ATTN: CHERIE TREGONING PHONE NO : 425 487 3157 8333 216TH ST., S.E. SE DECISION MADE: 28-FEB-11 WOODINVILLE WA 98072 510(k) STATEMENT DEVICE: VANGUARD ASYMMETRICAL PATELLAR COMPONENT BIOMET MANUFACTURING CORP. 510(k) NO: K110362(TRADITIONAL) ATTN: TAMARA WEST PHONE NO : 574 267 6639 56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 28-FEB-11 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KYPHON XPEDE BONE CEMENT MEDTRONIC 510(k) NO: K102397(TRADITIONAL) ATTN: MARY ROSE PHONE NO : 408 548 5203 1221 CROSSMAN AVE. SE DECISION MADE: 28-FEB-11 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORIN BIOLOX DELTA FEMORAL HEADS CORIN USA 510(k) NO: K103120(TRADITIONAL) ATTN: LUCINDA GERBER PHONE NO : 813 977 4469 10500 UNIVERSITY CENTER DRIVE SUITSE DECISION MADE: 28-FEB-11 TAMPA FL 33612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE FLEXBAR MACHINE CORP. 510(k) NO: K103840(TRADITIONAL) ATTN: STEPHEN T MLCOCH PHONE NO : 631 744 0059 30 NORTHPORT ROAD SE DECISION MADE: 28-FEB-11 SOUND BEACH NY 11764 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM LANX, INC. 510(k) NO: K103660(SPECIAL) ATTN: WILLIAM SANDUL PHONE NO : 303 501 8507 390 INTERLOCKEN CRESCENT SUITE 890SE DECISION MADE: 28-FEB-11 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTICOR K-WIRE SYSTEM VERTICOR, LTD 510(k) NO: K110047(TRADITIONAL) ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD. SE DECISION MADE: 28-FEB-11 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 255 TOTAL WITH SUMMARIES 237 TOTAL WITH STATEMENTS 18