SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-AUG-2008 THROUGH 31-AUG-2008 DEVICE: INTERCEPTOR PLUS CORONARY FILTER SYSTEMS MEDTRONIC INC. 510(k) NO: K073523(TRADITIONAL)
ATTN: COLLEEN MULLINS PHONE NO : 978-739-3267 37A CHERRY HILL DRIVE SE DECISION MADE: 01-AUG-08 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUNIVF DISHESINTL., INC. 510(k) NO: K080395(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700 393 SOUNDVIEW RD. SE DECISION MADE: 13-AUG-08 GUILFORD, CT 06437 510(k) STATEMENT DEVICE: RX ACCUNET LP EMBOLIC PROTECTION SYSTEM ABBOTT LABORATORIES 510(k) NO: K081549(TRADITIONAL)
ATTN: VIRGINIA SINGER PHONE NO : 408-845-0633 3200 LAKESIDE DRIVE SE DECISION MADE: 19-AUG-08 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIVERSAL CLAMP STAINLESS STEEL SYSTEM ABBOTT SPINE, INC. 510(k) NO: K081622(SPECIAL)
ATTN: MARITZA ELIAS PHONE NO : 512-533-1908 5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 29-AUG-08 AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM ABBOTT VASCULAR-VASCULAR SOLUTIONS510(k) NO: K072708(TRADITIONAL)
ATTN: MICHELLE GROSSMAN PHONE NO : 408-845-0613 3200 LAKESIDE DR. SE DECISION MADE: 18-AUG-08 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILVER ANTIMICROBIAL WOUND GEL ADVANCED MEDICAL SOLUTIONS LIMITED510(k) NO: K073197(TRADITIONAL)
ATTN: CLAIRE RYAN PHONE NO : 44 016 06863500 ROAD THREE SE DECISION MADE: 28-AUG-08 WINSFORD INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA WINSFORD CHESHIRE, UNITED KINGDOM CW7 3PD DEVICE: METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTE AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K081973(SPECIAL)
ATTN: MATTHEW M HULL PHONE NO : 610-984-9291 3773 CORPORATE PWKY. SE DECISION MADE: 07-AUG-08 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE ALATECH HEALTHCARE, LLC. 510(k) NO: K080606(ABBREVIATED)
ATTN: NEIL ANDERSON PHONE NO : 334-688-8520 1600 STATE DOCKS RD. SE DECISION MADE: 07-AUG-08 EUFAULA, AL 36027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASS CASUALTY VENTILATOR, MODEL MCV100 ALLIED HEALTHCARE PRODUCTS, INC. 510(k) NO: K080063(TRADITIONAL)
ATTN: WAYNE KARCHER PHONE NO : 314-771-2400 1720 SUBLETTE AVE. SE DECISION MADE: 15-AUG-08 ST. LOUIS, MO 63110 510(k) STATEMENT DEVICE: ALLTECH ECHOSTAR 1.5 T MR SYSTEM ALLTECH MEDICAL SYSTEMS AMERICA, I510(k) NO: K082100(TRADITIONAL)
ATTN: JOHN DURAJ PHONE NO : 440-424-2248 30825 AURORA ROAD SE DECISION MADE: 06-AUG-08 SUITE 100 510(k) STATEMENT SOLON, OH 44139 THIRD PARTY REVIEW DEVICE: RFVISION, MODEL 9.9D ALMANA MEDICAL IMAGING 510(k) NO: K080847(TRADITIONAL)
ATTN: DANIEL KAMM, P.E PHONE NO : 847-374-8854 PO BOX 7007 SE DECISION MADE: 06-AUG-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADVISION ET DIAGNOSTIC X-RAY SYSTEM ALMANA MEDICAL IMAGING 510(k) NO: K082064(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 PO BOX 7007 SE DECISION MADE: 22-AUG-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLEX CATHETER, MODEL SL2593 ALSIUS CORP. 510(k) NO: K081936(TRADITIONAL)
ATTN: JOHN RIOLO PHONE NO : 949-453-0150 15770 LAGUNA CANYON, SUITE 150 SE DECISION MADE: 13-AUG-08 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, B AMEDICA BIOTECH, INC. 510(k) NO: K080872(SPECIAL)
ATTN: JEFF CHEN PHONE NO : 510-785-5980 28301 INDUSTRIAL BLVD SUITE K SE DECISION MADE: 19-AUG-08 HAYWARD, CA 94545 510(k) STATEMENT DEVICE: RADIANCE AMERICAN ORTHODONTICS 510(k) NO: K080749(TRADITIONAL)
ATTN: JEROME H SCHOMBERG PHONE NO : 920-457-5051 1714 CAMBRIDGE AVE. SE DECISION MADE: 04-AUG-08 SHEBOYGAN, WI 53081 510(k) STATEMENT DEVICE: ANGIOSCULPT PTA SCORING BALLOON CATHETER ANGIOSCORE, INC. 510(k) NO: K082059(SPECIAL)
ATTN: KIMBERLEY KLINE PHONE NO : 510-933-7989 5055 BRANDIN COURT SE DECISION MADE: 11-AUG-08 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM AOTI LTD. 510(k) NO: K080966(TRADITIONAL)
ATTN: ROBBIE WALSH PHONE NO : 353 87 2355402 QUALTECH HOUSE SE DECISION MADE: 06-AUG-08 PARKMORE BUSINESS PARK WEST 510(k) SUMMARY AVAILABLE FROM FDA GALWAY, IRELAND DEVICE: SCANSCOPE XT SYSTEM APERIO TECHNOLOGIES 510(k) NO: K073677(TRADITIONAL)
ATTN: JEFF RYBERG PHONE NO : 760-539-1114 1430 VANTAGE COURT, SUITE 106 SE DECISION MADE: 01-AUG-08 VISTA, CA 92081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OVERSTITCH ENDOSCOPIC SUTURE SYSTEM APOLLO ENDOSURGERY, INC. 510(k) NO: K081853(TRADITIONAL)
ATTN: DENNIS MCWILLIAMS PHONE NO : 512-328-9990 7000 BEE CAVES RD. SUITE 350 SE DECISION MADE: 18-AUG-08 AUSTIN, TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APROXI 1100 AND 4000 SERIES DENTAL INLAYS APROXI APS 510(k) NO: K073047(ABBREVIATED)
ATTN: KIRSTEN RONO PHONE NO : 45 444 84124 HOJELOFT VAENGE 206 SE DECISION MADE: 07-AUG-08 VAERLOSE, DENMARK 510(k) STATEMENT DEVICE: ARTHROCARE ARTHROWANDS ARTHROCARE CORP. 510(k) NO: K082323(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224 680 VAQUEROS AVE. SE DECISION MADE: 28-AUG-08 SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDGE PACS ASHVA TECHNOLOGIES, PVT. LTD 510(k) NO: K081752(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1600 MANCHESTER WAY SE DECISION MADE: 06-AUG-08 CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SURGIMESH XB ASPIDE MEDICAL 510(k) NO: K072974(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813 555 THIRTEENTH ST. NW SE DECISION MADE: 18-AUG-08 COLUMBIA SQUARE 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20004-1109 DEVICE: ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG B. BRAUN MEDICAL, INC. 510(k) NO: K073396(TRADITIONAL)
ATTN: REBECCA STOLARICK PHONE NO : 610-596-2536 901 MARCON BLVD. SE DECISION MADE: 07-AUG-08 ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK BAUSCH & LOMB, INC 510(k) NO: K082132(SPECIAL)
ATTN: NED LUCE PHONE NO : 585-338-6368 1400 NORTH GOODMAN STREET SE DECISION MADE: 28-AUG-08 ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WI BAXTER HEALTHCARE CORP. 510(k) NO: K081289(TRADITIONAL)
ATTN: NANETTE HEDDEN PHONE NO : 847-270-4871 1620 WAUKEGAN ROAD SE DECISION MADE: 04-AUG-08 MCGAW PARK, IL 60085-6730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRICOS A RESORBABLE SUBSTITUTE BAXTER HEALTHCARE CORP. 510(k) NO: K081721(TRADITIONAL)
ATTN: BARBARA K BARBEAU PHONE NO : 847-270-4174 1620 WAUKEGAN ROAD SE DECISION MADE: 06-AUG-08 MCGAW PARK, IL 60085-6730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 BD BIOSCIENCES 510(k) NO: K081213(TRADITIONAL)
ATTN: NOBUKO NAKAJIMA PHONE NO : 408-954-4109 2350 QUME DR. SE DECISION MADE: 14-AUG-08 SAN JOSE, CA 95131-1807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MO BECKMAN COULTER, INC. 510(k) NO: K080634(TRADITIONAL)
ATTN: LYNN WEIST PHONE NO : 952-368-1271 1000 LAKE HAZELTINE DR. SE DECISION MADE: 11-AUG-08 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLOWCARE TLG REAGENT BECKMAN COULTER, INC. 510(k) NO: K081526(ABBREVIATED)
ATTN: NANCY NADLER PHONE NO : 305-380-4191 11800 SW 147TH AVE. SE DECISION MADE: 14-AUG-08 MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KYMCO FORU, MODEL EQ35 BESTEAM TECHNOLOGY INC. 510(k) NO: K081980(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 422 465396 14F-2 NO. 1 LANE 25 SE DECISION MADE: 04-AUG-08 ZHUANGJING RD. 510(k) SUMMARY AVAILABLE FROM FDA BANQIAO, CHINA (TAIWAN) 220 DEVICE: MODIFICATION TO GFX NERVE ABLATION SYSTEM BIOFORM MEDICAL, INC. 510(k) NO: K081729(SPECIAL)
ATTN: LORI HAYS PHONE NO : 262-835-3300 4133 COURTNEY ROAD, #10 SE DECISION MADE: 07-AUG-08 FRANKSVILLE, WI 53126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH BIOGENICS, INC. 510(k) NO: K081896(TRADITIONAL)
ATTN: LOU JONES PHONE NO : 707-224-7810 2797 NAPA VALLEY CORPORATE DR. SE DECISION MADE: 20-AUG-08 NAPA, CA 94558 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: HIPLOC COMPRESSION HIP SCREW BIOMET MANUFACTURING, INC. 510(k) NO: K080685(TRADITIONAL)
ATTN: BECKY EARL PHONE NO : 574-267-6639 P.O. BOX 587 SE DECISION MADE: 15-AUG-08 WARSAW, IN 46581-0578 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEEK-OPTIMA ALIF SPACER BIOMET SPINE 510(k) NO: K081636(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 973-299-9300 100 INTERPACE PARKWAY SE DECISION MADE: 07-AUG-08 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY BIOPLATE, INC. 510(k) NO: K082175(SPECIAL)
ATTN: JESUS T FARINAS PHONE NO : 310-815-2100 3643 LENAWEE AVE. SE DECISION MADE: 13-AUG-08 LOS ANGELES, CA 90016-4310 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPRO GO-EZ SCREW BIOPRO, INC. 510(k) NO: K081149(TRADITIONAL)
ATTN: DAVID MRAK PHONE NO : 810-982-7777 17 SEVENTEENTH ST. SE DECISION MADE: 05-AUG-08 PORT HURON, MI 48060 510(k) STATEMENT DEVICE: STEREOS WORKSTATION BIOSPACE MED 510(k) NO: K080529(TRADITIONAL)
ATTN: JOHN J SMITH PHONE NO : 202-637-3638 555 THIRTEENTH ST. NW SE DECISION MADE: 29-AUG-08 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE BLACKSTONE MEDICAL, INC. 510(k) NO: K081849(SPECIAL)
ATTN: WHITNEY G TORNING PHONE NO : 973-406-2838 1211 HAMBURG TURNPIKE SE DECISION MADE: 28-AUG-08 SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA WAYNE, NJ 07470 DEVICE: BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCES BONART CO. LTD. 510(k) NO: K080761(TRADITIONAL)
ATTN: ERIC L ONG PHONE NO : 909-594-8066 398 S. LEMON CREEK DR. SE DECISION MADE: 25-AUG-08 STE. L 510(k) STATEMENT WALNUT, CA 91789 DEVICE: BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO BONART CO. LTD. 510(k) NO: K081550(TRADITIONAL)
ATTN: ERIC L ONG PHONE NO : 909-594-8066 398 S. LEMON CREEK DR. SE DECISION MADE: 28-AUG-08 STE. L 510(k) STATEMENT WALNUT, CA 91789 DEVICE: KINETIX GUIDEWIRE, PLUS GUIDEWIRE BOSTON SCIENTIFIC CORP. 510(k) NO: K081021(TRADITIONAL)
ATTN: CHRISTINE THOMAS PHONE NO : 763-494-2942 ONE SCIMED PLACE A-380 SE DECISION MADE: 08-AUG-08 MAPLE GROVE, MN 55301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINNACLE PELVIC FLOOR REPAIR KIT II BOSTON SCIENTIFIC CORP. 510(k) NO: K081048(ABBREVIATED)
ATTN: MICHELLE BARRY PHONE NO : 508-683-4941 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 22-AUG-08 MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOSTON SCIENTIFIC SURGICAL MESH BOSTON SCIENTIFIC CORP. 510(k) NO: K081275(ABBREVIATED)
ATTN: JANET A MCGRATH PHONE NO : 508-683-4921 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 27-AUG-08 MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERLOC CLEAR SAFETY INFUSION SET C.R. BARD, INC. 510(k) NO: K082306(SPECIAL)
ATTN: HENRY BOLAND PHONE NO : 801-595-0700 605 NORTH 5600 WEST SE DECISION MADE: 28-AUG-08 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S CARDIAC SCIENCE CORPORATION 510(k) NO: K082173(SPECIAL)
ATTN: BEVERLY MAGRANE PHONE NO : 425-402-2365 3303 MONTE VILLA PKWY. SE DECISION MADE: 26-AUG-08 BOTHELL, WA 98021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, CARDINAL HEALTH 510(k) NO: K081464(TRADITIONAL)
ATTN: STEVE TAMSETT PHONE NO : 847-578-2325 1500 WAUKEGAN ROAD SE DECISION MADE: 28-AUG-08 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVEA VENTILATOR CARDINAL HEALTH 207, INC. 510(k) NO: K081837(SPECIAL)
ATTN: ANDRE VON MULLER PHONE NO : 714-283-8472 22745 SAVI RANCH PARKWAY SE DECISION MADE: 13-AUG-08 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTE CARDIO SYSTEMS, INC. 510(k) NO: K081944(SPECIAL)
ATTN: DAVID D BROOKE PHONE NO : 651-259-2061 651 CAMPUS DRIVE SE DECISION MADE: 14-AUG-08 SAINT PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MOD CARDIOMEMS INC 510(k) NO: K082191(ABBREVIATED)
ATTN: GRACE POWERS PHONE NO : 678-651-2323 387 TECHNOLOGY CIRCLE, NW SE DECISION MADE: 19-AUG-08 SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA ATLANTA, GA 30313 DEVICE: SELF-ADHESIVE ELECTRODES CATHAY HEALTHCARE EQUIPMENT MANUFA510(k) NO: K080276(TRADITIONAL)
ATTN: BRANDON CHOI PHONE NO : 562-943-4262 FLEMINGTON CT SE DECISION MADE: 04-AUG-08 SUITE 155 510(k) SUMMARY AVAILABLE FROM FDA LA MIRADA, CA 90638 DEVICE: OHMNISCAN NG CHRISTINE VALMY INC 510(k) NO: K073334(TRADITIONAL)
ATTN: PETER DEHAYDU PHONE NO : 973-575-1050 285, CHANGE BRIDGE ROAD SE DECISION MADE: 22-AUG-08 PINE BROOK, NJ 07058 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMPLATE AND COUNTER-FIT CLINICIAN'S CHOICE DENTAL PRODUCTS510(k) NO: K081017(TRADITIONAL)
ATTN: JEANETTE SMITH PHONE NO : 519 641 3066 1980 HYDE PARK ROAD SE DECISION MADE: 04-AUG-08 LONDON, ONTARIO, CANADA N6H 5L9 510(k) STATEMENT DEVICE: BAHA INTENSO COCHLEAR AMERICAS 510(k) NO: K081606(TRADITIONAL)
ATTN: SEAN BUNDY PHONE NO : 800-523-5798 400 INVERNESS PARKWAY, SE DECISION MADE: 28-AUG-08 SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA ENGLEWOOD, CO 80112 DEVICE: DERMABIOSAFE COMPLETE PRODUCT RESOURCES 510(k) NO: K080298(TRADITIONAL)
ATTN: JOHN WALSH PHONE NO : 949-757-0460 92 ARGONAUT # 200 SE DECISION MADE: 05-AUG-08 ALISO VIEJO, CA 92656 510(k) STATEMENT DEVICE: ATLAS-BASED AUTOSEGMENTATION COMPUTERIZED MEDICAL SYSTEMS, INC.510(k) NO: K080799(TRADITIONAL)
ATTN: KATHRYN STINSON PHONE NO : 314-993-0003 1145 CORPORATE LAKE DR. SE DECISION MADE: 07-AUG-08 ST. LOUIS, MO 63132-1716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO MERCI RETRIEVER CONCENTRIC MEDICAL, INC. 510(k) NO: K082034(SPECIAL)
ATTN: LARAINE PANGELINA PHONE NO : 650-938-2100 301 E. EVELYN AVE. SE DECISION MADE: 15-AUG-08 MOUNTAIN VIEW, CA 94041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APPROACH CTO WIRE GUIDE COOK INCORPORATED 510(k) NO: K081337(SPECIAL)
ATTN: KAREN BRADBURN PHONE NO : 812-339-2235 750 DANIELS WAY, P.O. BOX 489 SE DECISION MADE: 08-AUG-08 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ZILVER 635 BILIARY STENT COOK, INC. 510(k) NO: K080037(TRADITIONAL)
ATTN: STEPHANIE ROBERTS PHONE NO : 812-339-2235 750 DANIELS WAY PO BX 489 SE DECISION MADE: 01-AUG-08 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIRAFLEX HIGH FLOW MICROCATHETER COOK, INC. 510(k) NO: K080737(SPECIAL)
ATTN: NATHAN SIMON PHONE NO : 800-346-2686 750 DANIELS WAY PO BX 489 SE DECISION MADE: 08-AUG-08 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRO GUIDE CATHETER XP CORDIS CORP. 510(k) NO: K082143(SPECIAL)
ATTN: KAREN WILK PHONE NO : 908-412-7257 7 POWDER HORN DR. SE DECISION MADE: 25-AUG-08 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE CRAFTMASTER CONTOUR EQUIPMENT, INC510(k) NO: K081237(TRADITIONAL)
ATTN: STUART R GOLDMAN PHONE NO : 512-327-9997 1705 S. CAPITAL OF TEXAS HWY SE DECISION MADE: 25-AUG-08 SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78746 DEVICE: CURBELL PATIENT MONITORING CABLES CURBELL ELECTRONICS INC. 510(k) NO: K081762(ABBREVIATED)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412 5401 S. COTTONWOOD CT. SE DECISION MADE: 27-AUG-08 GREENWOOD VILLAGE, CO 80121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE CUTERA, INC. 510(k) NO: K080530(SPECIAL)
ATTN: KATHY MAYNOR PHONE NO : 415-657-5586 3240 BAYSHORE BLVD SE DECISION MADE: 15-AUG-08 BRISBANE, CA 94005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYGNUS 12 LEAD ECG MODULE CYGNUS, LLC 510(k) NO: K072950(TRADITIONAL)
ATTN: NARCIS NAYDENOV PHONE NO : 973-523-0668 510 EAST 41ST ST. SE DECISION MADE: 22-AUG-08 PATERSON, NJ 07504 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE DATEX-OHMEDA AVANCE DATEX-OHMEDA, INC. 510(k) NO: K081844(SPECIAL)
ATTN: ADRIENNE LENZ PHONE NO : 608-221-1551 PO BOX 7550 SE DECISION MADE: 29-AUG-08 3030 OHMEDA DR. 510(k) SUMMARY AVAILABLE FROM FDA MADISON, WI 53707 DEVICE: DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER DEPUY ORTHOPAEDICS, INC. 510(k) NO: K080990(TRADITIONAL)
ATTN: DAWN SINCLAIR PHONE NO : 574-372-5023 700 ORTHOPAEDIC DR. SE DECISION MADE: 08-AUG-08 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMALL BONE LOCKING PLATING SYSTEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K081546(TRADITIONAL)
ATTN: SUZANA OTANO PHONE NO : 305-269-6386 700 ORTHOPAEDIC DR. SE DECISION MADE: 26-AUG-08 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY C-STEM AMT DEPUY ORTHOPAEDICS, INC. 510(k) NO: K082239(SPECIAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4927 700 ORTHOPAEDIC DR. SE DECISION MADE: 29-AUG-08 WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEALOS II BONE GRAFT SUBSTITUTE DEPUY SPINE, INC. 510(k) NO: K081432(TRADITIONAL)
ATTN: HANDE TUFAN PHONE NO : 508-828-3065 325 PARAMOUNT DR. SE DECISION MADE: 29-AUG-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDILAS D FAMILY LASERS DORNIER MEDTECH AMERICA, INC. 510(k) NO: K073427(TRADITIONAL)
ATTN: THERON GOBER PHONE NO : 770-514-6204 1155 ROBERTS BLVD. SE DECISION MADE: 20-AUG-08 KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XERACEM DOXA DENTAL AB 510(k) NO: K081405(ABBREVIATED)
ATTN: JONATHAN KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET NW SE DECISION MADE: 21-AUG-08 COLUMBIA SQUARE 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20004 DEVICE: PICASSO MASTER, ECT AND MASTER 3D E-WOO TECHNOLOGY 510(k) NO: K081847(TRADITIONAL)
ATTN: DAVE KIM PHONE NO : 281-598-8124 256 NORTH SAM HOUSTON PKWY E. SE DECISION MADE: 21-AUG-08 SUITE 115 510(k) SUMMARY AVAILABLE FROM FDA HOUSTON, TX 77060 THIRD PARTY REVIEW DEVICE: ANYRAY PORTABLE X-RAY SYSTEM E-WOO TECHNOLOGY CO., LTD. 510(k) NO: K081899(TRADITIONAL)
ATTN: DAVE KIM PHONE NO : 281-598-8124 256 NORTH SAM HOUSTON PKWY E. SE DECISION MADE: 21-AUG-08 #115 510(k) SUMMARY AVAILABLE FROM FDA HOUSTON, TX 77060 THIRD PARTY REVIEW DEVICE: DSA 2000EX EIGEN LLC 510(k) NO: K082341(TRADITIONAL)
ATTN: ANIMESH KHEMKA PHONE NO : 530-274-1240 13366 GRASS VALLEY AVE. SE DECISION MADE: 29-AUG-08 GRASS VALLEY, CA 95945 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MLCI2 ELEKTA LTD. 510(k) NO: K082122(SPECIAL)
ATTN: PATRICK T HULL PHONE NO : 441 293 544422 LINAC HOUSE SE DECISION MADE: 29-AUG-08 FLEMING WAY, CRAWLEY 510(k) SUMMARY AVAILABLE FROM FDA WEST SUSSEX, UNITED KINGDOM RH10 9RR DEVICE: CLAROS NANO DENTAL LASER SYSTEM ELEXXION AG 510(k) NO: K081652(ABBREVIATED)
ATTN: HOLGER ERNST PHONE NO : 497 732 822990 SCHUETZENSTR. 84 SE DECISION MADE: 28-AUG-08 RADOLFZELL, GERMANY 78315 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMBLETTA GOLD EMBLA SYSTEMS, INC. 510(k) NO: K073682(TRADITIONAL)
ATTN: ROBERT G SCHUEPPERT PHONE NO : 303-962-1786 11001 W. 120TH AVE. SE DECISION MADE: 08-AUG-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA BROOMFIELD, CO 80021 DEVICE: REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MO ENCORE MEDICAL, L.P. 510(k) NO: K081679(SPECIAL)
ATTN: TEFFANY HUTTO PHONE NO : 512-834-6255 9800 METRIC BLVD. SE DECISION MADE: 20-AUG-08 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE T ESCADA INTERNATIONAL, INC. 510(k) NO: K080102(SPECIAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LN. SE DECISION MADE: 20-AUG-08 LITTLETON, CO 80127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTREMITY MEDICAL COMPRESSION SCREW EXTREMITY MEDICAL LLC 510(k) NO: K081934(TRADITIONAL)
ATTN: JAMY GANNOE PHONE NO : 973-316-9900 300 INTERPACE PARKWAY SE DECISION MADE: 29-AUG-08 SUITE 410 510(k) SUMMARY AVAILABLE FROM FDA PARSIPPANY, NJ 07054 DEVICE: DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL P FEG TEXTILTECHNIK FORSCHUNGS-UND E510(k) NO: K073579(TRADITIONAL)
ATTN: NEIL R ARMSTRONG PHONE NO : 011 441 763222505 BUSINESS & TECHNOLOGY CENTER/ SE DECISION MADE: 18-AUG-08 BESSEMER DRIVE 510(k) SUMMARY AVAILABLE FROM FDA STEVENAGE, UNITED KINGDOM SG1 2DX DEVICE: FIATLUX VISUALIZE FIATLUX IMAGING INC. 510(k) NO: K082041(TRADITIONAL)
ATTN: PHONE NO : 8430 154TH AVE. NE SE DECISION MADE: 01-AUG-08 REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M FOCUS DIAGNOSTICS, INC. 510(k) NO: K073381(TRADITIONAL)
ATTN: CONSTANCE BRIDGES PHONE NO : 714-503-2007 10703 PROGRESS WAY SE DECISION MADE: 04-AUG-08 CYPRESS, CA 90630-4737 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOSSA URETERAL OPEN STENTS FOSSA MEDICAL, INC. 510(k) NO: K072293(TRADITIONAL)
ATTN: GLORIA KOLB PHONE NO : 781-455-6704 50 REDFIELD STREET SE DECISION MADE: 06-AUG-08 BOSTON, MA 02122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION FUJIREBIO DIAGNOSTICS TEXAS, INC. 510(k) NO: K080273(TRADITIONAL)
ATTN: JOHN GORMLEY PHONE NO : 830-372-1301 940 CROSSROADS BLVD. SE DECISION MADE: 08-AUG-08 SEGUIN, TX 78155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FDTX GLUCOSE CONTROL SOLUTION FUJIREBIO DIAGNOSTICS TEXAS, INC. 510(k) NO: K081915(TRADITIONAL)
ATTN: JOHN GORMLEY PHONE NO : 830-372-1391 940 CROSSROADS BLVD. SE DECISION MADE: 08-AUG-08 SEGUIN, TX 78155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR FUKUDA DENSHI USA, INC. 510(k) NO: K081891(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 29-AUG-08 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW G & H WIRE CO. 510(k) NO: K081393(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-569-9500 11460 NORTH MERIDIAN STREET SE DECISION MADE: 21-AUG-08 SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA CARMEL, IN 46032 DEVICE: CENTRICITY PACS IW GE HEALTHCARE DYNAMIC IMAGING SOLU510(k) NO: K082318(SPECIAL)
ATTN: JILLIAN M REED PHONE NO : 203-459-0659 25 WALNUT ST. SE DECISION MADE: 25-AUG-08 MONROE, CT 06468 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVIGATOR APPLICATIONS SUITE GE HEALTHCARE FINLAND OY 510(k) NO: K081941(SPECIAL)
ATTN: ADRIENNE LENZ PHONE NO : 608-221-1551 3030 OHMEDA DRIVE SE DECISION MADE: 07-AUG-08 PO BOX 7550 510(k) SUMMARY AVAILABLE FROM FDA MADISON, WI 53707-7550 DEVICE: GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 520500 GE MEDICAL SYSTEMS ULTRASOUND AND 510(k) NO: K082185(SPECIAL)
ATTN: NICOLE LANDREVILLE PHONE NO : 414-721-2272 9900 INNOVATION DR. SE DECISION MADE: 15-AUG-08 WAUWATOSA, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE VIVID E9 ULTRASOUND GENERAL ELECTRIC CO. 510(k) NO: K081921(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-721-3992 9900 INNOVATION DRIVE SE DECISION MADE: 06-AUG-08 WAUWATOSA, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENTIAN CYSTATIN C IMMUNOASSAY GENTIAN AS 510(k) NO: K081875(SPECIAL)
ATTN: ERIC S GRUFF PHONE NO : 858-586-0751 9915 CAM. CHIRIMOLLA SE DECISION MADE: 20-AUG-08 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4 GLOBAL TOP, INC. 510(k) NO: K081200(TRADITIONAL)
ATTN: CLAUDE YANG PHONE NO : 082 256 63360 #708 LE-MEILLEUR TOWN, 837-19 SE DECISION MADE: 08-AUG-08 GANGNAM-GU 510(k) SUMMARY AVAILABLE FROM FDA SEOUL, REPUBLIC OF KOREA 135-937 DEVICE: LASERPEEL SOFT-MET MODIFIED ERBIUM LASER GLOBAL USA DISTRIBUTION, LLC. 510(k) NO: K082028(TRADITIONAL)
ATTN: MATT MAKOUSKY PHONE NO : 612-237-6928 10723 AQUILA AV. S. SE DECISION MADE: 08-AUG-08 MINNEAPOLIS, MN 55438 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMO GX CORPORATION SDN BHD 510(k) NO: K081315(TRADITIONAL)
ATTN: FOO K PU PHONE NO : 603 329 11600 LOT 6487, BATU 5 3/4, SEMENTA SE DECISION MADE: 11-AUG-08 JALAN KAPAR 510(k) STATEMENT KLANG, MALAYSIA 42100 DEVICE: GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AN GYRUS ACMI, INC. 510(k) NO: K082054(SPECIAL)
ATTN: TERRENCE E SULLIVAN PHONE NO : 508-804-2600 136 TURNPIKE RD. SE DECISION MADE: 06-AUG-08 SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PKS OMNI INSTRUMENT GYRUS-ACMI L.P. 510(k) NO: K081766(TRADITIONAL)
ATTN: LORRAINE CALZETTA PHONE NO : 508-804-2752 136 TURNPIKE RD. SE DECISION MADE: 08-AUG-08 SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER HANSEN MEDICAL, INC. 510(k) NO: K082075(SPECIAL)
ATTN: KATE WHITIN PHONE NO : 650-404-5841 800 E. MIDDLEFIELD ROAD SE DECISION MADE: 15-AUG-08 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/ HARVARD MEDICAL DEVICES LTD. 510(k) NO: K081159(TRADITIONAL)
ATTN: PAUL AYLETT PHONE NO : 852 273 52161 39 CHATHAM ROAD SOUTH SE DECISION MADE: 08-AUG-08 TSIMSHATSUI, KOWLOON, HONG KONG 510(k) STATEMENT DEVICE: MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC HEMCON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K072486(TRADITIONAL)
ATTN: KEVIN HAWKINS PHONE NO : 503-245-0459 10575 SW CASCADE AVENUE SE DECISION MADE: 06-AUG-08 SUITE 130 510(k) SUMMARY AVAILABLE FROM FDA PORTLAND, OR 97223-4363 DEVICE: ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K081745(TRADITIONAL)
ATTN: DOUG THISTLEWAITE PHONE NO : 330-425-1313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 12-AUG-08 TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 HOME DIAGNOSTICS, INC. 510(k) NO: K080641(TRADITIONAL)
ATTN: KAREN DEVINCENT PHONE NO : 954-677-9201 2400 N.W. 55TH CT. SE DECISION MADE: 19-AUG-08 FORT LAUDERDALE, FL 33309 510(k) STATEMENT DEVICE: TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81 HOME DIAGNOSTICS, INC. 510(k) NO: K080710(TRADITIONAL)
ATTN: KAREN DEVINCENT PHONE NO : 954-677-9201 2400 N.W. 55TH CT. SE DECISION MADE: 13-AUG-08 FORT LAUDERDALE, FL 33309 510(k) STATEMENT DEVICE: SCULPTURE 2.94 ER:YAG SYSTEM HOYA CONBIO, INC 510(k) NO: K073158(TRADITIONAL)
ATTN: LIZA BURNS PHONE NO : 209-586-0416 19722 WESTVIEW DRIVE SE DECISION MADE: 27-AUG-08 TWAIN HARTE, CA 95383 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS HSINER CO., LTD. 510(k) NO: K082009(SPECIAL)
ATTN: TOM SHANKS PHONE NO : 951-506-2674 29201 VIA NORTE SE DECISION MADE: 22-AUG-08 TEMECULA, CA 92591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BODY-JET HUMAN MED AG 510(k) NO: K082025(TRADITIONAL)
ATTN: INGE MATTHIESEN PHONE NO : 49 385 395700 WILHELM-HENNEMANN-STR.9 SE DECISION MADE: 13-AUG-08 SCHWERIN, GERMANY 19061 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, ICU MEDICAL INC 510(k) NO: K081361(TRADITIONAL)
ATTN: TRACY BEST PHONE NO : 801-264-1332 4455 ATHERTON DRIVE SE DECISION MADE: 28-AUG-08 SALT LAKE CITY, UT 84123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INAREX, MODEL 2D-LX INAREX CORPORATION 510(k) NO: K080554(TRADITIONAL)
ATTN: BRANDON CHOI PHONE NO : 562-943-4262 FLEMINGTON CT. # 155 SE DECISION MADE: 27-AUG-08 LA MIRADA, CA 90638 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER INJECTIMED, INC. 510(k) NO: K073664(TRADITIONAL)
ATTN: RICHARD G HUNTER PHONE NO : 770-851-1827 5616 MARIOLA PL NE SE DECISION MADE: 08-AUG-08 ALBUQUERQUE, NM 87111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IEC MEDSIGHT AND MEDBRIGHT INNOVATIVE ENDOSCOPY COMPONENTS, L510(k) NO: K080809(TRADITIONAL)
ATTN: GERALD GOIFITZER PHONE NO : 954-217-8780 731-733 SHOTGUN RD. SE DECISION MADE: 11-AUG-08 FT. LAUDERDALE, FL 33326 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INOMAX DS (DELIVERY SYSTEM), MODEL 10003 INO THERAPEUTICS 510(k) NO: K080484(SPECIAL)
ATTN: DAVID TRUEBLOOD PHONE NO : 608-395-3910 6 ROUTE 173 SE DECISION MADE: 06-AUG-08 CLINTON, NJ 08809 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INOMAX DS (DELIVERY SYSTEM) INO THERAPEUTICS LLC 510(k) NO: K081691(SPECIAL)
ATTN: DAVID TRUEBLOOD PHONE NO : 608-395-3910 2820 WALTON COMMONS WEST SE DECISION MADE: 28-AUG-08 MADISON, WI 53718 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTRUMED RONGEUR INSTRUMED INTERNATIONAL, INC. 510(k) NO: K081651(TRADITIONAL)
ATTN: MICHAEL MASSONG PHONE NO : 847-908-0292 626 COOPER COURT SE DECISION MADE: 08-AUG-08 SCHAUMBURG, IL 60173 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM INTEGRA RADIONICS, INC. 510(k) NO: K081459(TRADITIONAL)
ATTN: KEVIN J O'CONNELL PHONE NO : 781-565-1227 22 TERRY AVENUE SE DECISION MADE: 13-AUG-08 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGIMATCH ROBODOC SURGICAL SYSTEM INTEGRATED SURGICAL SYSTEMS, INC. 510(k) NO: K072629(TRADITIONAL)
ATTN: RUSS HIBBERT PHONE NO : 916-285-9943 1433 N. MARKET BLVD., #1 SE DECISION MADE: 06-AUG-08 SACREMENTO, CA 95834 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 INTUITIVE SURGICAL, INC. 510(k) NO: K073112(TRADITIONAL)
ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2100 950 KIFER RD. SE DECISION MADE: 01-AUG-08 SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FAMILI OF IRIDEX IQ LASER SYSTEMS IRIDEX CORP. 510(k) NO: K071687(TRADITIONAL)
ATTN: DAVID BUZAWA PHONE NO : 650-962-8848 1212 TERRA BELLA AVE. SE DECISION MADE: 07-AUG-08 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER IRVINE BIOMEDICAL, INC. 510(k) NO: K082061(SPECIAL)
ATTN: JEANETTE HENDRICKSON PHONE NO : 949-769-5006 2375 MORSE AVE. SE DECISION MADE: 19-AUG-08 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATCH-PAT 200S-2 (WP200S-2) ITAMAR MEDICAL 510(k) NO: K081982(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 14-AUG-08 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TM-400 ITO CO., LTD. 510(k) NO: K081247(TRADITIONAL)
ATTN: KENNETH L BLOCK PHONE NO : 972-480-9554 1201 RICHARDSON DR., SUITE 140 SE DECISION MADE: 25-AUG-08 RICHARDSON, TX 75080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW) JIANGSU CUREGUARD GLOVE CO., LTD. 510(k) NO: K081657(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 108 2387441 ROOM 1606 BLDG. 1 JIANX. YUAN SE DECISION MADE: 20-AUG-08 NO. 209 BEI SI HUAN ZHONG RD. 510(k) SUMMARY AVAILABLE FROM FDA HAIDIAN DISTRICT, BEIJING, CHINA 100083 DEVICE: HAIDA MODEL HD11 MANUAL WHEELCHAIR JIANGYIN EAST CHINA MEDICAL TECHNO510(k) NO: K082274(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 4 22465396 14F-2, NO. 1, ZHUANGJING RD. SE DECISION MADE: 19-AUG-08 LANE 25 510(k) SUMMARY AVAILABLE FROM FDA BANQIAO, CHINA (TAIWAN) 220 DEVICE: HAIDA HD21 JIANGYIN EAST CHINA MEDICAL TECHNO510(k) NO: K082288(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 422 465396 14F-2, NO. 1, ZHUANGJING RD. SE DECISION MADE: 19-AUG-08 LANE 25 510(k) SUMMARY AVAILABLE FROM FDA BANQIAO, CHINA (TAIWAN) 220 DEVICE: JMEA CANNULATED BONE SCREW SYSTEM JMEA CORPORATION 510(k) NO: K080259(TRADITIONAL)
ATTN: SAM SON PHONE NO : 410-746-9583 1 RESEARCH COURT SE DECISION MADE: 20-AUG-08 SUITE 450 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20850 DEVICE: ORTHO ALL-FLEX DIAPHRAGM JOHNSON & JOHNSON PRODUTOS PROFISS510(k) NO: K080040(TRADITIONAL)
ATTN: WILLIAM GREENROSE PHONE NO : 603-369-3550 220 RIVER ROAD SE DECISION MADE: 25-AUG-08 CLAREMONT, NH 03743-5647 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DMC COMPOSITE KERR CORP. 510(k) NO: K081695(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714-516-7602 1717 W. COLLINS AVENUE SE DECISION MADE: 12-AUG-08 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KETTOSIL AND SILGINAT KETTENBACH GMBH & CO KG 510(k) NO: K082157(TRADITIONAL)
ATTN: MICHAELA ZINKE PHONE NO : 49 277 470558 IM HEERFELD 7 SE DECISION MADE: 06-AUG-08 ESCHENBURG, GERMANY 35713 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VOLUMINA KJAYA MEDICAL, LLC 510(k) NO: K081215(TRADITIONAL)
ATTN: KOVALAN MUNIANDY PHONE NO : 203-653-3496 263 TRESSER BLVD., 9TH FLOOR SE DECISION MADE: 26-AUG-08 STAMFORD, CT 06901 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TAXI ENDOSCOPIC GUIDEWIRE LAKE REGION MFG., INC. 510(k) NO: K081708(TRADITIONAL)
ATTN: DEEP PAL PHONE NO : 952-448-5111 340 LAKE HAZELTINE DR. SE DECISION MADE: 26-AUG-08 CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 LAURIMED LLC 510(k) NO: K082194(TRADITIONAL)
ATTN: NANCY LINCE PHONE NO : 650-587-5296 500 ARGUELLO STREET, SUITE 100 SE DECISION MADE: 28-AUG-08 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MSC LIPID CONTROL MAINE STANDARDS CO. 510(k) NO: K082067(TRADITIONAL)
ATTN: HOLLY CRESSMAN PHONE NO : 207-892-1300 765 ROOSEVELT TRAIL SE DECISION MADE: 22-AUG-08 WINDHAM, ME 04062-5365 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAX ADJUSTING INSTRUMENT MANNA OMNI INTERNATIONAL INC. 510(k) NO: K082218(TRADITIONAL)
ATTN: STEPHEN TSAI PHONE NO : 714-871-7118 340 E. COMMONWEALTH AVE. SE DECISION MADE: 13-AUG-08 FULLERTON, CA 92832 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-INSIGHT MAZOR SURGICAL TECHNOLOGIES LTD. 510(k) NO: K081672(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 9 7670002 20 HATA'AS ST. SE DECISION MADE: 15-AUG-08 KFAR SABA, ISRAEL 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MESACUP MODELS BP180 AND BP230 ELISA KITS MBL INTERNATIONAL CORPORATION 510(k) NO: K071961(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 PO BOX 7007 SE DECISION MADE: 25-AUG-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNASSIGNED MEDCOMP 510(k) NO: K080544(TRADITIONAL)
ATTN: JEAN CALLOW PHONE NO : 215-256-4201 1499 DELP DR. SE DECISION MADE: 14-AUG-08 HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRILAZE LASER ABLATION SYSTEM MEDICALCV, INC. 510(k) NO: K081457(TRADITIONAL)
ATTN: KIRK S HONOUR PHONE NO : 651-452-3000 9725 SOUTH ROBERT TRAIL SE DECISION MADE: 08-AUG-08 INVER GROVE HEIGHTS, MN 55077 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENESIS MEDISISS 510(k) NO: K081559(TRADITIONAL)
ATTN: BRANDI JAMES PHONE NO : 541-923-3310 2747 SW 6TH STREET SE DECISION MADE: 28-AUG-08 REDMOND, OR 97756 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCTIC BLAST INTRAVENOUS FLUID CHILLER MEDIVANCE, INC. 510(k) NO: K080899(TRADITIONAL)
ATTN: LYNNE ARONSON PHONE NO : 303-926-1917 1172 CENTURY DR., SUITE 240 SE DECISION MADE: 07-AUG-08 LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT MEDSOURCE INTERNATIONAL, LLC. 510(k) NO: K081516(TRADITIONAL)
ATTN: PHONE NO : 5346 SHORELINE DR. SE DECISION MADE: 26-AUG-08 MOUND, MN 55364 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PIONEER PLUS CATHETER MEDTRONIC INC. 510(k) NO: K081804(TRADITIONAL)
ATTN: CATHERINE PRIESTLEY PHONE NO : 707-591-7205 3576 UNOCAL PLACE SE DECISION MADE: 05-AUG-08 SANTA ROSA, CA 95403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 4 MEDTRONIC NEUROSURGERY 510(k) NO: K082127(SPECIAL)
ATTN: JEFFREY HENDERSON PHONE NO : 805-571-8445 125 CREMONA DR. SE DECISION MADE: 27-AUG-08 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K081038(TRADITIONAL)
ATTN: CHRIS MCKEE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 15-AUG-08 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T2 XVBR SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K082112(SPECIAL)
ATTN: MELISA LANSKY PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 27-AUG-08 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESCUE EXTERNAL IMPLANT SYSTEM MEGAGEN IMPLANT CO., LTD 510(k) NO: K081302(TRADITIONAL)
ATTN: JUNG B BANG PHONE NO : 562-404-8466 13340 E. FIRESTONE BLVD. SE DECISION MADE: 15-AUG-08 SUITE J 510(k) SUMMARY AVAILABLE FROM FDA SANTA FE SPRINGS, CA 90670 DEVICE: EZ REGULAR MEINNTECH CO., LTD. 510(k) NO: K080303(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 PO BOX 7007 SE DECISION MADE: 05-AUG-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXIUM DETACHABLE COIL SYSTEM MICRO THERAPEUTICS, INC. 510(k) NO: K081465(TRADITIONAL)
ATTN: NEELU MEDHEKAR PHONE NO : 949-837-3700 9775 TOLEDO WAY SE DECISION MADE: 19-AUG-08 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRUS ASCENT OCCLUSION BALLOON CATHETER MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K080861(TRADITIONAL)
ATTN: PATRICK LEE PHONE NO : 408-433-1428 821 FOX LANE SE DECISION MADE: 27-AUG-08 SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SKINSENSE POLYISOPRENE UNDERGLOVE MOLNLYCKE HEALTH CARE US, LLC 510(k) NO: K081180(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 678-250-7930 5550 PEACHTREE PARKWAY SE DECISION MADE: 26-AUG-08 SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA NORCROSS, GA 30092 DEVICE: SYGNAL DBM MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K080405(TRADITIONAL)
ATTN: NANCY BENNEWITZ JOY PHONE NO : 732-661-2381 125 MAY ST, STE 300 SE DECISION MADE: 28-AUG-08 EDISON CORP CTR 510(k) SUMMARY AVAILABLE FROM FDA EDISON, NJ 08837 DEVICE: PAINSHIELD MD NANO VIBRONIX LTD. 510(k) NO: K081075(TRADITIONAL)
ATTN: ELI ORBACH PHONE NO : 972 299 32768 POB 6718 SE DECISION MADE: 22-AUG-08 EFRAT, ISRAEL 90435 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A NIHON KOHDEN AMERICA, INC. 510(k) NO: K080546(SPECIAL)
ATTN: JACK COGGAN PHONE NO : 949-580-1555 90 ICON ST. SE DECISION MADE: 29-AUG-08 FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORAS MR-BI320-PA 3T NORAS MRI PRODUCTS GMBH 510(k) NO: K082373(ABBREVIATED) ATTN: PATRICIA KRAPF PHONE NO : 49 931 2992719 LEIBNITZSTRASSE 4 SE DECISION MADE: 29-AUG-08 HOECHBERG, GERMANY 97204 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TCM ENDO 20 NOUVAG AG 510(k) NO: K081191(TRADITIONAL)
ATTN: ERICH FORSTER PHONE NO : 041 56 2019500 REUSSWEHRSTRASSE 1 SE DECISION MADE: 07-AUG-08 GEBENSTORF, SWITZERLAND CH-5412 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATIO OMNIGUIDE, INC. 510(k) NO: K081939(TRADITIONAL)
ATTN: DOUGLAS W WOODRUFF PHONE NO : 617-551-8404 ONE KENDALL SQUARE, BLDG 100 SE DECISION MADE: 12-AUG-08 3RD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA CAMBRIDGE, MA 02139 THIRD PARTY REVIEW DEVICE: VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCT ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K082099(SPECIAL)
ATTN: MARLENE A HANNA PHONE NO : 585-453-404 100 INDIGO CREEK DR. SE DECISION MADE: 21-AUG-08 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OTA COLLAGEN BIOMATERIAL OSSEOUS TECHNOLOGIES OF AMERICA 510(k) NO: K073685(TRADITIONAL)
ATTN: DAVID J COLLETTE PHONE NO : 858-792-1235 11234 EL CAMINO REAL SE DECISION MADE: 29-AUG-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92130 DEVICE: OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COA OSTEOMED L.P. 510(k) NO: K081876(SPECIAL)
ATTN: ALMA RELJA PHONE NO : 972-677-4781 3885 ARAPAHO RD. SE DECISION MADE: 01-AUG-08 ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM PATHWAY MEDICAL TECHNOLOGIES, INC.510(k) NO: K082186(SPECIAL)
ATTN: BRIAN CLEARY PHONE NO : 425-636-4079 10801 120TH AVENUE NE SE DECISION MADE: 29-AUG-08 KIRKLAND, WA 98033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUTE-IT II VENEER CEMENT, MODEL NO6 PENTRON CLINICAL TECHNOLOGIES 510(k) NO: K081887(TRADITIONAL) ATTN: GREG MOREAU PHONE NO : 203-265-7397 68-70 NORTH PLAINS INDUSTRIAL SE DECISION MADE: 29-AUG-08 ROAD 510(k) SUMMARY AVAILABLE FROM FDA WALLINGFORD, CT 06492 DEVICE: PERIMETRICS PERIOMETER PERIMETRICS, INC. 510(k) NO: K072213(TRADITIONAL)
ATTN: ALBERT REGO PHONE NO : 949-770-8710 27001 LA PAZ, SUITE 314 SE DECISION MADE: 29-AUG-08 MISSION VIEJO, CA 92691 510(k) STATEMENT DEVICE: M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00 PHILIPS MEDICAL SYSTEMS 510(k) NO: K081983(SPECIAL)
ATTN: CLAIRE ARAKAKI PHONE NO : 978-659-4348 3000 MINUTEMEN RD. SE DECISION MADE: 22-AUG-08 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULE PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K081937(SPECIAL)
ATTN: JENS-PETER SEHER PHONE NO : 49 703 14632086 HEWLETT-PACKARD STR.2 SE DECISION MADE: 29-AUG-08 BOEBLINGEN, GERMANY D-71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC PIONEER SURGICAL TECHNOLOGY 510(k) NO: K081558(TRADITIONAL)
ATTN: JONATHAN GILBERT PHONE NO : 906-226-4812 375 RIVER PARK CIRCLE SE DECISION MADE: 25-AUG-08 MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLANMECA SOVEREIGN PLANMECA USA, INC. 510(k) NO: K081699(TRADITIONAL)
ATTN: BOB PIENKOWSKI PHONE NO : 630-529-2300 100 N. GARY AVE. SUITE A SE DECISION MADE: 29-AUG-08 ROSELLE, IL 60172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES PRAXIM 510(k) NO: K081232(TRADITIONAL)
ATTN: ANNIE POLLIER PHONE NO : 33 4 76549503 LE GRAND SABLON SE DECISION MADE: 06-AUG-08 4 AVENUE DE L'OBIOU 510(k) SUMMARY AVAILABLE FROM FDA LA TRONCHE, FRANCE 38700 DEVICE: MAPERSOL PRESERVATION SOLUTIONS, INC. 510(k) NO: K080432(TRADITIONAL)
ATTN: NEIL BURRIS PHONE NO : 720-323-1662 4250 GROVE STREET SE DECISION MADE: 08-AUG-08 DENVER, CO 80211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE M PRIMED MEDICAL PRODUCTS INC. 510(k) NO: K081633(SPECIAL)
ATTN: RAYMOND G MARUSYK PHONE NO : 780 497 7600 SUITE 900, 10707-100 AVE. SE DECISION MADE: 11-AUG-08 EDMONTON, ALBERTA, CANADA T5J 3M1 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM PRONIA MEDICAL SYSTEM, LLC 510(k) NO: K081388(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207 49 PLAIN STREET SE DECISION MADE: 21-AUG-08 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE PT. MAJA AGUNG LATEXINDO 510(k) NO: K081488(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 909-591-8855 5445 DANIELS ST. SE DECISION MADE: 28-AUG-08 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AP 34 MULTI-THERAPY INFUSION PUMP Q-CORE, LTD 510(k) NO: K082182(TRADITIONAL)
ATTN: ASHER KASSEL PHONE NO : 972 732 388888 PO BOX 3341 SE DECISION MADE: 15-AUG-08 14 HAMEFALSIM ST. KIRYAT ARYEH 510(k) SUMMARY AVAILABLE FROM FDA PETACH TIKVA, ISRAEL 49130 THIRD PARTY REVIEW DEVICE: REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C REACH SURGICAL, INC 510(k) NO: K071023(TRADITIONAL)
ATTN: RICH GRANT PHONE NO : 513-769-1916 4480 LAKE FOREST DR. SE DECISION MADE: 28-AUG-08 SUITE 414 510(k) SUMMARY AVAILABLE FROM FDA CINCINNATI, OH 45242 DEVICE: OCULAR RESPONSE ANALYZER REICHERT INC. 510(k) NO: K081756(TRADITIONAL)
ATTN: SANDRA BROWN PHONE NO : 718-686-4599 3362 WALDEN AVE. SE DECISION MADE: 07-AUG-08 DEPEW, NY 14043 510(k) STATEMENT DEVICE: RHYTEC, INC., PORTRAIT PSR RHYTEC INCORPORATED 510(k) NO: K082197(SPECIAL)
ATTN: ROBERT ZOLETTI PHONE NO : 781-419-9482 130 TURNER STREET SE DECISION MADE: 22-AUG-08 BUILDING 2 510(k) SUMMARY AVAILABLE FROM FDA WALTHAM, MA 02453 DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR RICH MOUNTAIN MEDICAL PRODUCTS, IN510(k) NO: K081535(ABBREVIATED)
ATTN: MICHELLE SHIH PHONE NO : 011 886 266003631 NO. 8, JIANG YIN ROAD SE DECISION MADE: 14-AUG-08 YI TANG TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA PIZHOU, JIANGSU, CHINA DEVICE: ELECSYS ANTI-TSHR CALCHECK ROCHE DIAGNOSTICS 510(k) NO: K080643(TRADITIONAL)
ATTN: STEPHANIE GREEMAN PHONE NO : 317-521-2458 9115 HAGUE RD. SE DECISION MADE: 22-AUG-08 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARRIAZO-PENDULAR MICROKERATOME SCHWIND EYE-TECH-SOLUTIONS GMBH & 510(k) NO: K082043(TRADITIONAL)
ATTN: ROLF SCHWIND PHONE NO : 49 602 75080 MAINPARKSTRASSE 6-10 SE DECISION MADE: 01-AUG-08 KLEINOSTHEIM, GERMANY 63801 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, SENORX, INC. 510(k) NO: K081085(TRADITIONAL)
ATTN: EBEN GORDON PHONE NO : 949-362-4800 11 COLUMBIA SE DECISION MADE: 01-AUG-08 ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FINDRWIRZ GUIDE WIRE SYSTEM SENTREHEART INC. 510(k) NO: K080364(TRADITIONAL)
ATTN: LINDA GUTHRIE PHONE NO : 650-354-1200 2468 EMBARCADERO WAY SE DECISION MADE: 11-AUG-08 PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN SHENYANG CANTA MEDICAL TECH CO., L510(k) NO: K081508(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 216 4264467 SUITE 8D, NO. 19, LANE 999 SE DECISION MADE: 27-AUG-08 ZHONGSHAN NO.2 ROAD (S) 510(k) SUMMARY AVAILABLE FROM FDA SHANGHAI, CHINA 200030 DEVICE: MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM SICEL TECHNOLOGIES, INC. 510(k) NO: K081859(SPECIAL)
ATTN: SUZANNE SCHWALLER PHONE NO : 919-465-2236 3800 GATEWAY CENTRE BLVD. SE DECISION MADE: 04-AUG-08 SUITE 308 510(k) SUMMARY AVAILABLE FROM FDA MORRISVILLE, NC 27560 DEVICE: MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL SIEMENS 510(k) NO: K081182(TRADITIONAL)
ATTN: LIBBY WARRINER PHONE NO : 916-374-3244 1584 ENTERPRISE BLVD. SE DECISION MADE: 08-AUG-08 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K080167(TRADITIONAL)
ATTN: PHILIP LIU PHONE NO : 914-524-2443 511 BENEDICT AVENUE SE DECISION MADE: 08-AUG-08 TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K081731(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376 SE DECISION MADE: 29-AUG-08 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VIS SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K081299(TRADITIONAL)
ATTN: RADAMES RIESGO PHONE NO : 305-480-7558 500 GBC DRIVE SE DECISION MADE: 08-AUG-08 MS 514 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19702 DEVICE: DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC5 SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K081319(ABBREVIATED)
ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798 500 GBC DRIVE SE DECISION MADE: 04-AUG-08 MS 514 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19702 DEVICE: DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K081992(SPECIAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626 PO BOX 6101 SE DECISION MADE: 05-AUG-08 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K082030(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626 PO BOX 6101 SE DECISION MADE: 22-AUG-08 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: YSIO SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K081722(TRADITIONAL)
ATTN: GARY JOHNSON PHONE NO : 610-448-1787 51 VALLEY STREAM PKWY. SE DECISION MADE: 22-AUG-08 MS E-50 510(k) SUMMARY AVAILABLE FROM FDA MALVERN, PA 19355 DEVICE: XIOS PLUS WALL-MODULE SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K081903(TRADITIONAL)
ATTN: FRITZ KOLLE PHONE NO : 49 625 1163294 FABRIKSTRASSE 31 SE DECISION MADE: 26-AUG-08 BENSHEIM, GERMANY D-64625 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: 2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S SMITH & NEPHEW, INC. 510(k) NO: K081511(TRADITIONAL)
ATTN: JANICE HASELTON PHONE NO : 978-749-1494 150 MINUTEMAN RD. SE DECISION MADE: 26-AUG-08 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW OXINIUM DH FEMORAL HEADS SMITH & NEPHEW, INC. 510(k) NO: K081566(SPECIAL)
ATTN: JASON SELLS PHONE NO : 901-399-5520 1450 E BROOKS ROAD SE DECISION MADE: 21-AUG-08 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SI SMITHS MEDICAL ASD, INC. 510(k) NO: K081086(TRADITIONAL)
ATTN: JOHN TULLETT PHONE NO : 44 130 3260551 MILITARY ROAD SE DECISION MADE: 13-AUG-08 HYTHE, KENT, UNITED KINGDOM CT216J510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARIETEX COMPOSITE MONO PM MESH SOFRADIM PRODUCTION 510(k) NO: K081126(TRADITIONAL)
ATTN: SHARON ALEXANDER PHONE NO : 203-492-6060 60 MIDDLETOWN AVENUE SE DECISION MADE: 13-AUG-08 NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOSITE MAXX SERIES ULTRASOUND SYSTEM SONOSITE,INC. 510(k) NO: K082098(TRADITIONAL)
ATTN: CHRISTOPHER J HARTZOG PHONE NO : 425-951-1419 21919 30TH DRIVE SE. SE DECISION MADE: 25-AUG-08 BOTHELL, WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 SPACELABS MEDICAL INC. 510(k) NO: K082045(SPECIAL)
ATTN: TIM DAVIS PHONE NO : 812-614-5072 2235 EAST FLAMINGO RD. SE DECISION MADE: 01-AUG-08 SUITE 201G 510(k) SUMMARY AVAILABLE FROM FDA LAS VEGAS, NV 89119 DEVICE: MODIFICATION TO LUCENT SPINAL ELEMENTS, INC. 510(k) NO: K081968(SPECIAL)
ATTN: KERRI DIMARTINO PHONE NO : 760-607-1816 2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 05-AUG-08 CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE SPINE VIEW, INC. 510(k) NO: K081051(TRADITIONAL)
ATTN: ROY CHIN PHONE NO : 510-377-0898 48541 WARM SPRINGS BLVD. SE DECISION MADE: 07-AUG-08 SUITE 507 510(k) SUMMARY AVAILABLE FROM FDA FREMONT, CA 94539 DEVICE: SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL D ST. JUDE MEDICAL 510(k) NO: K081365(TRADITIONAL)
ATTN: ELIZABETH E NEELY PHONE NO : 408-522-6494 701 EAST EVELYN AVENUE SE DECISION MADE: 15-AUG-08 SUNNYVALE, CA 94086-6527 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROLL-X GUIDEWIRE ST. JUDE MEDICAL 510(k) NO: K082304(TRADITIONAL)
ATTN: JEFF STURM PHONE NO : 763-383-2640 14901 DEVEAU PL. SE DECISION MADE: 27-AUG-08 MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS STEREOTAXIS, INC. 510(k) NO: K080637(TRADITIONAL)
ATTN: DENNIS POZZO PHONE NO : 341-678-6136 4320 FOREST PARK AVENUE SE DECISION MADE: 12-AUG-08 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA ST. LOUIS, MO 63108 DEVICE: REPROCESSED EXTERNAL FIXATION ACCESSORIES STERILMED, INC. 510(k) NO: K081342(TRADITIONAL)
ATTN: JOSHUA CLARIN PHONE NO : 763-488-3483 11400 73RD AVE. NORTH SE DECISION MADE: 13-AUG-08 MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED EXTERNAL FIXATION DEVICE STERILMED, INC. 510(k) NO: K081586(TRADITIONAL)
ATTN: JOSHUA CLARIN PHONE NO : 612-644-8402 11140 73RD AVE. NORTH SE DECISION MADE: 18-AUG-08 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERIS RESERT XL TEST STRIP STERIS CORPORATION 510(k) NO: K081600(TRADITIONAL)
ATTN: JOHN SCOVILLE PHONE NO : 440-392-7330 5960 HEISLEY RD. SE DECISION MADE: 22-AUG-08 MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 10 STERITEC PRODUCTS, INC. 510(k) NO: K080136(TRADITIONAL)
ATTN: LINDA NELSON PHONE NO : 303-660-4201 599 TOPEKA WAY, SUITE 400 SE DECISION MADE: 15-AUG-08 CASTLE ROCK, CO 80109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER ESSX MICRODEBRIDER SYSTEM STRYKER IRELAND LTD., INSTRUMENTS 510(k) NO: K073633(TRADITIONAL)
ATTN: COLETTE O'CONNOR PHONE NO : 353 21 4532978 CARRIGTWOHILL BUSINESS & SE DECISION MADE: 26-AUG-08 TECHNOLOGY PARK 510(k) SUMMARY AVAILABLE FROM FDA CARRIGTWOHILL, CO.CORK, IRELAND DEVICE: DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES SUNRISE MEDICAL 510(k) NO: K081468(TRADITIONAL)
ATTN: JOSEPH E OLSAVSKY PHONE NO : 814-443-7602 100 DEVILBISS DR. SE DECISION MADE: 25-AUG-08 SOMERSET, PA 15501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE SURGICAL CONCEPT DESIGNS 510(k) NO: K081476(TRADITIONAL)
ATTN: CHRISTOPHER SCOTT PHONE NO : 201-456-9164 307 PROSPECT AVENUE SE DECISION MADE: 08-AUG-08 SUITE 2G 510(k) SUMMARY AVAILABLE FROM FDA HACKENSACK, NJ 07601 DEVICE: SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EX SYNTHES (USA) 510(k) NO: K082148(TRADITIONAL) ATTN: JILL R SHERMAN PHONE NO : 610-719-6538 1301 GOSHEN PKWY. SE DECISION MADE: 11-AUG-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER SYSMEX AMERICA, INC. 510(k) NO: K081610(TRADITIONAL)
ATTN: NINA GAMPERLING PHONE NO : 847-996-4675 ONE NELSON C. WHITE PARKWAY SE DECISION MADE: 29-AUG-08 MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A; TD-1261B TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K081445(TRADITIONAL)
ATTN: YUHUA CHEN PHONE NO : 886 266 258188 6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 11-AUG-08 WUGU TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA TAIPEI COUNTY, CHINA (TAIWAN) 248 DEVICE: U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K081957(SPECIAL)
ATTN: YUHUA CHEN PHONE NO : 886 266 258188 6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 05-AUG-08 WUGU TOWNSHIP 510(k) STATEMENT TAIPEI COUNTY, CHINA (TAIWAN) 241 DEVICE: BIOACTIF OSTEOTRANS INTERFENCE SCREW TAKIRON CO., LTD 510(k) NO: K081390(TRADITIONAL)
ATTN: KUNIHIRO HATA PHONE NO : 81 78 3062601 7-1-19, MINATOJIMAMINAMIMACHI, SE DECISION MADE: 12-AUG-08 CHUO-KU 510(k) SUMMARY AVAILABLE FROM FDA KOBE, HYOGO, JAPAN 650-0047 DEVICE: HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED TE ME NA SAS 510(k) NO: K080603(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 962 ALLEGRO LANE SE DECISION MADE: 05-AUG-08 APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPACITY + BONE CEMENT TEKNIMED SA 510(k) NO: K080873(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD SE DECISION MADE: 28-AUG-08 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: "LOVE GUARD" MALE LATEX CONDOM TIANJIN HUMAN-CARE LATEX CORPORATI510(k) NO: K080833(ABBREVIATED)
ATTN: SIMON LI PHONE NO : 609-649-2723 56 DANVILLE DRIVE SE DECISION MADE: 07-AUG-08 WEST WINDSOR, NJ 08550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO HI-ART TREATMENT SYSTEM TOMOTHERAPY INCORPORATED 510(k) NO: K082005(TRADITIONAL)
ATTN: ROBERT BOVY PHONE NO : 608-824-2938 1209 DEMING WAY SE DECISION MADE: 25-AUG-08 MADISON, WI 53717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K082119(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR SE DECISION MADE: 12-AUG-08 TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PCA-8000A, MARK 11, PET / CT SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K082244(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 21-AUG-08 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92781-2068 THIRD PARTY REVIEW DEVICE: TRAUSON BONE PLATE TRAUSON (JIANGSU) MEDICAL INSTRUME510(k) NO: K073432(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 64264467 LANE 999, ZHONGSHAN NO. 2 ROAD SE DECISION MADE: 13-AUG-08 SUITE 8D, NO. 19 510(k) SUMMARY AVAILABLE FROM FDA SHANGHAI, CHINA 200030 DEVICE: CENTURION PROTECTIVE RESTRAINT, SCR SERIES TRI-STATE HOSPITAL SUPPLY CORP. 510(k) NO: K080448(TRADITIONAL)
ATTN: MATTHEW K PRICE PHONE NO : 517-546-5400 301 CATRELL DR. SE DECISION MADE: 28-AUG-08 HOWELL, MI 48843 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIGER CANNULATED SCREW SYSTEM TRILLIANT SURGICAL LTD 510(k) NO: K081510(TRADITIONAL)
ATTN: J. D WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD SE DECISION MADE: 04-AUG-08 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 9 TRIMLINE MEDICAL PRODUCTS CORP. 510(k) NO: K080189(ABBREVIATED)
ATTN: NANCY SKOCYPEC PHONE NO : 908-429-0590 34 COLUMBIA AVE. SE DECISION MADE: 15-AUG-08 BRANCHBURG, NJ 08876 510(k) STATEMENT DEVICE: TRITON MEIDCAL TMED IV-SET TRITON MEDICAL, LLC 510(k) NO: K073444(TRADITIONAL)
ATTN: IAN P GORDON PHONE NO : 512-327-9997 1705 S. CAPITAL OF TEXAS HWY SE DECISION MADE: 18-AUG-08 AUSTIN, TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER TRUDELL MEDICAL INTL. 510(k) NO: K080926(TRADITIONAL)
ATTN: DARRYL FISCHER PHONE NO : 519 455 7060 2140 725 THIRD ST. SE DECISION MADE: 12-AUG-08 LONDON, ONTARIO, CANADA N5V 5G4 510(k) STATEMENT DEVICE: TYSONBIO LINK HEALTH MANAGEMENT SYSTEM TYSON BIORESEARCH, INC. 510(k) NO: K081726(TRADITIONAL)
ATTN: WEN-HAI TSAI PHONE NO : 886 37 585988 5 F., # 22, KE TUNG RD., SE DECISION MADE: 26-AUG-08 SCIENCE BASED INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA CHUN-NAN, MIAO-LI COUNTY, CHINA (TAIWAN) 350 DEVICE: MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS U-SYSTEM, INC. 510(k) NO: K080930(TRADITIONAL)
ATTN: LISA SCOTT PHONE NO : 408-571-0777 110 ROSE ORCHARD WAY SE DECISION MADE: 07-AUG-08 SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONIX MDP ULTRASOUND SCANNER ULTRASONIX MEDICAL CORPORATION 510(k) NO: K080935(TRADITIONAL)
ATTN: ALAN REMFRY PHONE NO : 604 437 9500 130-4311 VIKING WAY SE DECISION MADE: 06-AUG-08 RICHMOND, BRITISH COLUMBIA, CANADA510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SERIES SY DISPOSABLE ELECTROSURGICAL PAD VENTLAB CORP. 510(k) NO: K082204(TRADITIONAL)
ATTN: CHRISTINA NORRIS PHONE NO : 410-451-0639 1676 VILLAGE GREEN STE A SE DECISION MADE: 13-AUG-08 CROFTON, MD 21114-4341 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: PROVENT NASAL CANNULA VENTUS MEDICAL, INC. 510(k) NO: K080983(TRADITIONAL)
ATTN: CINDY DOMECUS PHONE NO : 650-343-4813 1301 SHOREWAY ROAD SE DECISION MADE: 07-AUG-08 SUITE 340 510(k) SUMMARY AVAILABLE FROM FDA BELMONT, CA 94002 DEVICE: VERISTA IMAGING ISOCAM II GAMMA CAMERA VERISTA IMAGING INC. 510(k) NO: K081757(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD. SE DECISION MADE: 15-AUG-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: VIP PULMONARY FUNCTION SYSTEM VIASYS HEALTHCARE GMBH 510(k) NO: K080510(SPECIAL)
ATTN: THOMAS RUST PHONE NO : 499 314 972383 LEIBNIZSTRASSE 7 SE DECISION MADE: 20-AUG-08 HOECHBERG, GERMANY 97204 510(k) STATEMENT DEVICE: NEUROCATH AG VYGON NEURO 510(k) NO: K081942(SPECIAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300 2495 GENERAL ARMISTEAD AVE. SE DECISION MADE: 12-AUG-08 NORRISTOWN, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE W. L. GORE & ASSOCIATES, INC. 510(k) NO: K082356(SPECIAL)
ATTN: ALICIA HEMPHILL PHONE NO : 928-864-4328 3450 WEST KILTIE LANE SE DECISION MADE: 28-AUG-08 FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODEL WALLAC OY 510(k) NO: K071649(TRADITIONAL)
ATTN: CINDY LLOYD PHONE NO : 781-663-5818 940 WINTER STREET SE DECISION MADE: 07-AUG-08 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WEBERNEEDLE BASIC LASER WEBER MEDICAL GMBH 510(k) NO: K073352(TRADITIONAL)
ATTN: JURGEN HERMANN PHONE NO : 499 856 922959 SOHNREYSTRASSE 6 SE DECISION MADE: 11-AUG-08 LAURENFORDE, NIEDERSACHSEN, GERMAN510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ANEROID SPHYGMOMANOMETER, MODEL KT-A01 WENZHOU KINDCARE IMPORT & EXPORT C510(k) NO: K081951(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931-937-8093 340 SHADY GROVE ROAD SE DECISION MADE: 15-AUG-08 FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: WESTAR SERIES DENTAL UNITS WESTAR MEDICAL PRODUCTS, INC. 510(k) NO: K082294(TRADITIONAL)
ATTN: RUTH HALLER PHONE NO : 425-290-3945 4470 CHENNAULT BEACH RD SE DECISION MADE: 22-AUG-08 SUITE 2 510(k) STATEMENT MUKILTEO, WA 98275 THIRD PARTY REVIEW DEVICE: WINCO MODEL POWER SERIES LIFT CHAIR WINCO, INC. 510(k) NO: K080533(TRADITIONAL)
ATTN: JIM ANKOVIAK PHONE NO : 352-854-2929 5516 S.W. FIRST LN. SE DECISION MADE: 11-AUG-08 OCALA, FL 34474 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMBOCARE 2000 XANACARE TECHNOLOGIES, LLC 510(k) NO: K081141(TRADITIONAL)
ATTN: ROBERT N CLARK PHONE NO : 303-463-0900 13605 W. 7TH AVE. SE DECISION MADE: 29-AUG-08 GOLDEN, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALLOMAP MOLECULAR EXPRESSION TESTING XDX 510(k) NO: K073482(TRADITIONAL) ATTN: ROSE ROMEO PHONE NO : 415-287-2396 3260 BAYSHORE BOULEVARD SE DECISION MADE: 08-AUG-08 BRISBANE, CA 94005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIP XODUS MEDICAL, INC. 510(k) NO: K081647(TRADITIONAL) ATTN: BRENDA NIEL PHONE NO : 724-337-5500 702 PROMINENCE DR. SE DECISION MADE: 12-AUG-08 NEW KENSINGTON, PA 15068 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES ZIMMER, INC. 510(k) NO: K073499(TRADITIONAL)
ATTN: ERIC S PITTMAN PHONE NO : 574-371-8369 P.O. BOX 708 SE DECISION MADE: 07-AUG-08 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 244 TOTAL WITH SUMMARIES 220 TOTAL WITH STATEMENTS 24
Updated September 5, 2008
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