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510(k)s Final Decisions Rendered for August 2005 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-AUG-2005 THROUGH 31-AUG-2005 DEVICE: 3L SURGICAL DRAPES 3L MEDICAL PRODUCTS CO., LTD. 510(k) NO: K043015(TRADITIONAL)
ATTN: GEORGE SU PHONE NO : 310-229-5748 1800 CENTURY PARK EAST SE DECISION MADE: 15-AUG-05 SUITE 600 510(k) SUMMARY AVAILABLE FROM FDA CENTURY CITY, CA 90067 DEVICE: 3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER 3M COMPANY 510(k) NO: K052128(SPECIAL)
ATTN: CYNTHIA LAMANRUCCIOLA PHONE NO : 651-736-1523 3M CENTER, BLDG. 260-2B-17 SE DECISION MADE: 16-AUG-05 ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A-DEC SELF-CONTAINED WATER SYSTEM A-DEC, INC. 510(k) NO: K051657(TRADITIONAL)
ATTN: TOM LOUISELL PHONE NO : 503-538-9471 2601 CRESTVIEW DR. SE DECISION MADE: 30-AUG-05 NEWBERG, OR 97132-9257 510(k) STATEMENT DEVICE: FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC. 510(k) NO: K051802(SPECIAL)
ATTN: KIMBERLEY KLINE PHONE NO : 510-749-5478 1360 SOUTH LOOP RD. SE DECISION MADE: 09-AUG-05 ALAMEDA, CA 94502-7000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABBOTT AXSYM B12 ABBOTT LABORATORIES 510(k) NO: K051327(TRADITIONAL)
ATTN: MARGARET PROCHNIAK PHONE NO : 847-937-4106 100 ABBOTT PARK RD. SE DECISION MADE: 03-AUG-05 ABBOTT PARK, IL 60064-6095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRA HDL ABBOTT LABORATORIES 510(k) NO: K051962(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711 1920 HURD DRIVE SE DECISION MADE: 25-AUG-05 IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL ABBOTT SPINE, INC. 510(k) NO: K052072(SPECIAL)
ATTN: NOAH BARTSCH PHONE NO : 512-533-1840 5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 29-AUG-05 AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIEVA SINUS BALLOON INFLATION DEVICE ACCLARENT, INC. 510(k) NO: K052198(TRADITIONAL)
ATTN: SU-MIEN CHONG PHONE NO : 650-687-5858 1525-B O'BRIEN DR. SE DECISION MADE: 31-AUG-05 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIFYNOW-P2Y12 ASSAY ACCUMETRICS, INC. 510(k) NO: K051231(TRADITIONAL)
ATTN: BARBARA STEVENS PHONE NO : 858-404-8281 3985 B SORRENTO VALLEY BLVD. SE DECISION MADE: 05-AUG-05 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM ACCURAY, INC. 510(k) NO: K051941(SPECIAL)
ATTN: ANNE SCHLAGENHAFT PHONE NO : 408-716-4628 1310 CHESAPEAKE TERRACE SE DECISION MADE: 09-AUG-05 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL ACMI CORPORATION 510(k) NO: K052044(SPECIAL)
ATTN: TERRENCE E SULLIVAN PHONE NO : 508-804-2739 136 TURNPIKE RD. SE DECISION MADE: 16-AUG-05 SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIABSORB COMPOSITE SCREW ADVANCED BIOMATERIALS 510(k) NO: K050468(TRADITIONAL)
ATTN: PATRICK JANIN PHONE NO : 011 334 92123256 265 ROUTE DE LA BARONNE SE DECISION MADE: 31-AUG-05 ST. JEANNET, FRANCE 06640 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERRAD STERILIZER CYCLESURE TEST PACK ADVANCED STERILIZATION PRODUCTS 510(k) NO: K051643(TRADITIONAL)
ATTN: JOSEPH M ASCENZI PHONE NO : 949-453-6352 33 TECHNOLOGY DR. SE DECISION MADE: 19-AUG-05 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRYSTAR MODEL 5500 AGFA CORPORATION 510(k) NO: K052251(TRADITIONAL)
ATTN: JEFF JEDLICKA PHONE NO : 864-421-1815 10 SOUTH ACADEMY STREET SE DECISION MADE: 31-AUG-05 GREENVILLE, SC 29602-9048 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVIC ALLIANCE MEDICAL CORP. 510(k) NO: K052062(SPECIAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5300 10232 SOUTH 51ST ST. SE DECISION MADE: 25-AUG-05 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVIC ALLIANCE MEDICAL CORP. 510(k) NO: K052064(SPECIAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5300 10232 SOUTH 51ST ST. SE DECISION MADE: 25-AUG-05 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVIC ALLIANCE MEDICAL CORP. 510(k) NO: K052065(SPECIAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5300 10232 SOUTH 51ST ST. SE DECISION MADE: 22-AUG-05 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMBU NEUROLINE GROUND AMBU, INC. 510(k) NO: K051529(TRADITIONAL)
ATTN: SANJAY PARIKH PHONE NO : 410-768-6464 6740 BAYMEADOW DR. SE DECISION MADE: 04-AUG-05 GLEN BURNIE, MD 21060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMS PELVIC FLOOR REPAIR SYSTEM AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K051485(TRADITIONAL)
ATTN: ELSA LINKE PHONE NO : 952-930-6309 10700 BREN RD., WEST SE DECISION MADE: 03-AUG-05 MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P ANGIOMETRX INC. 510(k) NO: K051042(TRADITIONAL)
ATTN: TIM VERSPAGEN PHONE NO : 604 742 3810 1099 8TH AVENUE WEST SE DECISION MADE: 05-AUG-05 UNIT 107 510(k) SUMMARY AVAILABLE FROM FDA VANCOUVER, BC, CANADA V6H 1C3 DEVICE: GR17 DIGITAL DETECTOR ANRAD CORP. 510(k) NO: K052136(SPECIAL) ATTN: DONALD J SHERRATT PHONE NO : 978-977-3000 8 CENTENNIAL DRIVE SE DECISION MADE: 25-AUG-05 PEABODY, MA 01960 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY ANSELL HEALTHCARE PRODUCTS, LLC 510(k) NO: K051793(TRADITIONAL)
ATTN: CYNTHIA A INGRAM PHONE NO : 334-615-2563 1635 INDUSTRIAL ROAD SE DECISION MADE: 17-AUG-05 DOTHAN, AL 36303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INCLOSE SURGICAL MESH SYSTEM ANULEX TECHNOLOGIES, INC 510(k) NO: K050969(TRADITIONAL)
ATTN: TIM MILLER PHONE NO : 952-224-4003 5600 ROWLAND ROAD, STE 280 SE DECISION MADE: 18-AUG-05 MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM AS SOFTWARE, INC. 510(k) NO: K051639(ABBREVIATED)
ATTN: KIM A NATHANSON PHONE NO : 201-541-1900 80 SOUTH WOODLAND STREET SE DECISION MADE: 02-AUG-05 ENGLEWOOD, NJ 07631 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAHI PTCA GUIDE WIRE FIELDER ASAHI INTECC CO., LTD. 510(k) NO: K052022(SPECIAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252 1301 DOVE STREET, SUITE #350 SE DECISION MADE: 25-AUG-05 NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT ASCENDIA MEDTECH AB 510(k) NO: K050320(TRADITIONAL)
ATTN: JANE B CAMPBELL PHONE NO : 845-469-4289 485 LAROE ROAD SE DECISION MADE: 15-AUG-05 CHESTER, NY 10918 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100 AVENT AMERICA, INC. 510(k) NO: K051413(TRADITIONAL)
ATTN: RICHARD MORRONEY PHONE NO : 508-872-2878 1 SPEEN STREET SE DECISION MADE: 29-AUG-05 SUITE 160 510(k) SUMMARY AVAILABLE FROM FDA FRAMINGHAM, MA 01701 DEVICE: AXIOM NVP8500 AXIOM WORLDWIDE, INC. 510(k) NO: K051135(TRADITIONAL)
ATTN: JAMES J GIBSON PHONE NO : 813-249-6444 9423 CORPORATE LAKE DRIVE SE DECISION MADE: 11-AUG-05 TAMPA, FL 33634 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECLIPSE NEUROLOGICAL WORKSTATION AXON SYSTEMS, INC. 510(k) NO: K050798(TRADITIONAL)
ATTN: HOWARD BAILIN PHONE NO : 631-436-5112 400-2200 OSER AVE. SE DECISION MADE: 15-AUG-05 HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR AXYA MEDICAL, INC. 510(k) NO: K051983(SPECIAL)
ATTN: HOWARD SCHRAYER PHONE NO : 609-924-9610 100 CUMMINGS CENTER SE DECISION MADE: 05-AUG-05 SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA BEVERLY, MA 01915 DEVICE: POWDER-FREE VINYL EXAM GLOVES BAODING GUANZHONG GLOVE CO., LTD. 510(k) NO: K052006(TRADITIONAL)
ATTN: MARY ANN DOUCETTE PHONE NO : 760-318-4973 10 SETON COURT SE DECISION MADE: 03-AUG-05 RANCHO MIRAGE, CA 92270 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIO 3MP-21" BARCOVIEW 510(k) NO: K051901(TRADITIONAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 325 623 3459 35 PRESIDENT KENNEDYPARK SE DECISION MADE: 17-AUG-05 KORTRIJK, BELGIUM B-8500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIO 2MP-21" BARCOVIEW 510(k) NO: K051902(TRADITIONAL) ATTN: LIEVEN DE WANDEL PHONE NO : 325 623 3459 35 PRESIDENT KENNEDYPARK SE DECISION MADE: 11-AUG-05 KORTRIJK, BELGIUM B-8500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP BARD PERIPHERAL VASCULAR, INC. 510(k) NO: K052114(SPECIAL)
ATTN: DENNIS SALZMANN PHONE NO : 480-894-9515 P.O. BOX 1740 SE DECISION MADE: 25-AUG-05 TEMPE, AZ 85280-1740 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD ATLAS PTA BALLOON DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC. 510(k) NO: K052236(SPECIAL)
ATTN: GENEVIEVE BALUTOWSKI PHONE NO : 480-303-2524 1625 WEST 3RD ST. SE DECISION MADE: 23-AUG-05 P.O. BOX 1740 510(k) SUMMARY AVAILABLE FROM FDA TEMPE, AZ 85280 DEVICE: STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, M BAXTER HEALTHCARE CORP. 510(k) NO: K051370(TRADITIONAL)
ATTN: NANETTE HEDDEN PHONE NO : 847-473-6281 1620 WAUKEGAN RD., MPGR-AL SE DECISION MADE: 12-AUG-05 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIPOPROTEIN FOR MULTIPLE ANALYTES BAYER HEALTHCARE, LLC 510(k) NO: K051619(ABBREVIATED)
ATTN: ANDERS HOLLE PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 01-AUG-05 TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ITAG MHC TETRAMER CMV ASSAY BECKMAN COULTER, INC. 510(k) NO: K051122(TRADITIONAL)
ATTN: MARA CALER PHONE NO : 858-621-4583 7330 CARROLL RD. SE DECISION MADE: 01-AUG-05 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 BECKMAN COULTER, INC. 510(k) NO: K052082(SPECIAL)
ATTN: CAROLYN ANDERSON PHONE NO : 952-368-7869 1000 LAKE HAZELTINE DR. SE DECISION MADE: 19-AUG-05 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - DAPTOMYCIN 0.125 - 32 BECTON, DICKINSON & CO. 510(k) NO: K051689(TRADITIONAL)
ATTN: MONICA GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 05-AUG-05 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CEEGRAPH/SLEEPSCAN NETLINK TRAVELER BIO-LOGIC SYSTEMS CORP. 510(k) NO: K052066(SPECIAL)
ATTN: NORMAN E BRUNNER PHONE NO : 800-323-8326 ONE BIOLOGIC PLAZA SE DECISION MADE: 26-AUG-05 MUNDELEIN, IL 60060-3700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITI BIO-RAD 510(k) NO: K052053(TRADITIONAL)
ATTN: SUZANNE S PARSONS PHONE NO : 949-598-1467 9500 JERONIMO RD. SE DECISION MADE: 09-AUG-05 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMIWAVE 1X4 INFRARED THERAPY DEVICE BIOCARE SYSTEMS, INC. 510(k) NO: K051816(SPECIAL)
ATTN: CLAY ANSELMO PHONE NO : 303-223-4315 518 17TH STREET SE DECISION MADE: 26-AUG-05 SUITE 1350 510(k) SUMMARY AVAILABLE FROM FDA DENVER, CO 80202 DEVICE: FORTOSS VITAL BONE GRAFT SUBSTITUTE BIOCOMPOSITES LTD. 510(k) NO: K050170(TRADITIONAL)
ATTN: SIMON FITZER PHONE NO : 44 178 2338590 KEELE SCIENCE PARK SE DECISION MADE: 26-AUG-05 KEELE, STAFFORDSHIRE, UNITED KINGD510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTIA IGE BIOKIT S.A. 510(k) NO: K050493(TRADITIONAL)
ATTN: JOAN GUIXER PHONE NO : 011 349 38609000 CAN MALE LLISSA D'AMUNT SE DECISION MADE: 16-AUG-05 BARCELONA, SPAIN 08186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTIA BETA-2 MICROGLOBULIN BIOKIT S.A. 510(k) NO: K050613(TRADITIONAL)
ATTN: JOAN GUIXER PHONE NO : 011 349 38609000 LLISSA D'AMUNT SE DECISION MADE: 16-AUG-05 BARCELONA, SPAIN 08186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 100W CERALAS D 980 LASER SYSTEM, MODEL D100 BIOLITEC, INC. 510(k) NO: K050824(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH ST., NW SE DECISION MADE: 10-AUG-05 WASHINGTON, DC 20004-5910 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM BIOMEDIX, INC. 510(k) NO: K050182(TRADITIONAL)
ATTN: JUDY S CHEN PHONE NO : 510-449-1554 40471 ENCYCLOPEDIA CIRCLE SE DECISION MADE: 09-AUG-05 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. 510(k) NO: K051849(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695 595 ANGLUM DR. SE DECISION MADE: 16-AUG-05 HAZELWOOD, MO 63042-2320 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COM BIOMET MANUFACTURING, INC. 510(k) NO: K051479(TRADITIONAL)
ATTN: GARY BAKER PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 10-AUG-05 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM BIOMET, INC. 510(k) NO: K043547(TRADITIONAL)
ATTN: GARY BAKER PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 05-AUG-05 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS BIOMET, INC. 510(k) NO: K050222(SPECIAL)
ATTN: GARY BAKER PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 16-AUG-05 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE BIOMET, INC. 510(k) NO: K051385(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 05-AUG-05 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBALT BONE CEMENT BIOMET, INC. 510(k) NO: K051496(TRADITIONAL)
ATTN: LONNIE WITHAM PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 04-AUG-05 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46582 DEVICE: COBALT G HV BONE CEMENT BIOMET, INC. 510(k) NO: K051532(TRADITIONAL)
ATTN: LONNIE WITHAM PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 03-AUG-05 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVL HINGE KNEE SYSTEM BIOMET, INC. 510(k) NO: K051570(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 05-AUG-05 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) BIOVALVE TECHNOLOGIES, INC. 510(k) NO: K050971(TRADITIONAL)
ATTN: SCOTT HUIE PHONE NO : 508-366-2300 155 FLANDERS RD. SE DECISION MADE: 16-AUG-05 WESTBOROUGH, MA 01581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOVALVE MINI-JECT NEEDLEFREE INJECTOR BIOVALVE TECHNOLOGIES, INC. 510(k) NO: K051985(SPECIAL)
ATTN: SCOTT HUIE PHONE NO : 508-366-2300 155 FLANDERS RD. SE DECISION MADE: 17-AUG-05 WESTBOROUGH, MA 01581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO DUET SYSTEM BIOVIEW LTD. 510(k) NO: K050840(TRADITIONAL)
ATTN: DORIT WINITZ PHONE NO : 972 3 6123281 11 MENACHEM BEGIN ST. SE DECISION MADE: 16-AUG-05 RAMAT-GAN, ISRAEL 52521 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BISCOVER LED BISCO, INC. 510(k) NO: K051999(TRADITIONAL)
ATTN: BENJAMIN LICHTENWALNER PHONE NO : 847-534-6146 1100 WEST IRVING PARK RD. SE DECISION MADE: 22-AUG-05 SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR BOSTON SCIENTIFIC CORP. 510(k) NO: K052194(TRADITIONAL)
ATTN: ALLYSON BARFORD PHONE NO : 508-683-4356 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 24-AUG-05 MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIV BOSTON SCIENTIFIC CORPORATION 510(k) NO: K052038(SPECIAL)
ATTN: RENUKA KRISHNAN PHONE NO : 858-503-1815 3574 RUFFIN ROAD SE DECISION MADE: 16-AUG-05 SAN DIEGO, CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C CHANGE SOLUTION WARMER C CHANGE SURGICAL LLC 510(k) NO: K051819(TRADITIONAL)
ATTN: ROBERT KELLY PHONE NO : 336-748-0686 101 NORTH CHESTNUT STREET SE DECISION MADE: 15-AUG-05 SUITE 301 510(k) SUMMARY AVAILABLE FROM FDA WINSTON-SALEM, NC 27101 DEVICE: MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F C.R. BARD, INC. 510(k) NO: K050558(TRADITIONAL)
ATTN: KAREN HUTCHISON PHONE NO : 480-303-2539 1625 WEST 3RD ST. SE DECISION MADE: 29-AUG-05 P.O. BOX 1740 510(k) SUMMARY AVAILABLE FROM FDA TEMPE, AZ 85281-1740 DEVICE: HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIAL C.R. BARD, INC. 510(k) NO: K051748(SPECIAL)
ATTN: MICHAELA RIVKOWICH PHONE NO : 801-595-0700 5425 WEST AMELIA EARHART DR. SE DECISION MADE: 12-AUG-05 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0 CAMTRONICS MEDICAL SYSTEMS 510(k) NO: K051649(TRADITIONAL)
ATTN: STEVE KRUEGER PHONE NO : 262-912-3422 900 WALNUT RIDGE DR. SE DECISION MADE: 02-AUG-05 HARTLAND, WI 53029 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANADY PLASMA PROBES CANADY TECHNOLOGY, LLC 510(k) NO: K052035(TRADITIONAL)
ATTN: JEROME CANADY PHONE NO : 757-857-7450 24 RESEARCH DR. SE DECISION MADE: 31-AUG-05 HAMPTON, VA 23666 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM CARDINAL HEALTH 510(k) NO: K050994(TRADITIONAL)
ATTN: SHARON NICHOLS PHONE NO : 847-578-6610 1430 WAUKEGAN RD. SE DECISION MADE: 03-AUG-05 BUILDING KB 510(k) SUMMARY AVAILABLE FROM FDA MCGAW PARK, IL 60085 DEVICE: CARDIOSTREAM SONOAIM CARDIOSTREAM, LLC 510(k) NO: K051853(TRADITIONAL)
ATTN: IAN P GORDON PHONE NO : 727-797-4727 2454 MCMULLEN BOOTH RD SE DECISION MADE: 22-AUG-05 STE 427 510(k) SUMMARY AVAILABLE FROM FDA CLEARWATER, FL 33759 DEVICE: AQUIFY MULTIPURPOSE SOLUTION CIBA VISION CORPORATION 510(k) NO: K050250(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 678-415-3897 11460 JOHNS CREEK PARKWAY SE DECISION MADE: 10-AUG-05 DULUTH, GA 30097 510(k) STATEMENT DEVICE: 506 PATIENT MONITOR CIRITICARE SYSTEMS, INC. 510(k) NO: K051038(TRADITIONAL)
ATTN: ALEX KAPLAN PHONE NO : 262-798-8282 20925 CROSSROADS CIRCLE SE DECISION MADE: 12-AUG-05 WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I-STOP CL MEDICAL 510(k) NO: K051533(TRADITIONAL)
ATTN: VINCENT GORIA PHONE NO : 33 04 78595493 28 AVENUE GENERAL DE GAULLE SE DECISION MADE: 11-AUG-05 SAINTE FOY LES LYON, FRANCE 69110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS COLLAGEN MATRIX, INC. 510(k) NO: K043034(TRADITIONAL)
ATTN: PEGGY HANSEN PHONE NO : 201-405-1477 509 COMMERCE ST. SE DECISION MADE: 04-AUG-05 FRANKLIN LAKES,, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTE COLTENE/WHALEDENT INC. 510(k) NO: K051660(TRADITIONAL)
ATTN: LORETTA MOONEY PHONE NO : 330-916-8800 235 ASCOT PARKWAY SE DECISION MADE: 04-AUG-05 CUYAHOGA FALLS, OH 44223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS BREAST COIL CONFIRMA, INC. 510(k) NO: K052045(TRADITIONAL)
ATTN: PATRICIA A MILBANK PHONE NO : 425-894-9733 821 KIRKLAND AVE. SE DECISION MADE: 24-AUG-05 KIRKLAND, WA 98033-6318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORMULA 418 BILIARY STENT COOK, INC. 510(k) NO: K051785(TRADITIONAL)
ATTN: KAREN BRADBURN PHONE NO : 812-339-2235 750 DANIELS WAY PO BX 489 SE DECISION MADE: 23-AUG-05 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATB ADVANCE PTA DILATATION CATHETER COOK, INC. 510(k) NO: K052036(SPECIAL)
ATTN: KAREN BRADBURN PHONE NO : 800-346-2686 750 DANIELS WAY PO BX 489 SE DECISION MADE: 25-AUG-05 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIGLIDE UNICONDYLAR KNEE PROSTHESIS CORIN U.S.A. 510(k) NO: K050764(TRADITIONAL)
ATTN: JOEL BATTS PHONE NO : 813-977-4469 10500 UNIVERSITY CENTER DR., SE DECISION MADE: 24-AUG-05 SUITE 190 510(k) SUMMARY AVAILABLE FROM FDA TAMPA, FL 33612 DEVICE: REGENSIS PERICARDIAL PATCH CORMATRIX CARDIOVASCULAR, INC. 510(k) NO: K051405(TRADITIONAL)
ATTN: PUNAM GOLLAMUDI PHONE NO : 408-400-0856 155 MOFFETT PARK DRIVE SE DECISION MADE: 31-AUG-05 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH CRS MEDICAL DIAGNOSTICS INC. 510(k) NO: K050889(TRADITIONAL)
ATTN: JOSEPH M MATTANO PHONE NO : 262-264-0047 662 CAPITOL DRIVE SE DECISION MADE: 26-AUG-05 PEWAUKEE, WI 53072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLAR CATH PERIPHERAL DILATATION SYSTEM CRYOVASCULAR SYSTEMS, INC. 510(k) NO: K051916(SPECIAL)
ATTN: ELAINE APLAON PHONE NO : 408-866-3204 160 KNOWLES DR. SE DECISION MADE: 05-AUG-05 LOS GATOS, CA 95032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-10 CS MEDICAL LLC 510(k) NO: K051305(TRADITIONAL)
ATTN: BEN CHEMELLI PHONE NO : 919-255-3220 3248 LAKE WOODARD DR. SE DECISION MADE: 18-AUG-05 RALEIGH, NC 27604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VCS S3T CYCLING AND HEALTH TECH. INDUSTRY 510(k) NO: K051131(TRADITIONAL)
ATTN: CHANG WAN LAN PHONE NO : 886 4 23501100 NO. 17, 37TH RD., SE DECISION MADE: 15-AUG-05 TAICHUNG INDUSTRY PARK 510(k) SUMMARY AVAILABLE FROM FDA TAICHUNG, CHINA (TAIWAN) 40768 DEVICE: STRATUS CS D-DIMER DADE BEHRING, INC. 510(k) NO: K051597(TRADITIONAL)
ATTN: KATHLEEN A DRAY-LYONS PHONE NO : 781-826-4551 GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 17-AUG-05 BLDG. 500 M.S. 514 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: TRIO MONITOR DATASCOPE CORP. 510(k) NO: K051897(SPECIAL)
ATTN: SUSAN E MANDY PHONE NO : 201-995-8025 800 MACARTHUR BLVD. SE DECISION MADE: 12-AUG-05 MAHWAH, NJ 07430-0619 510(k) STATEMENT DEVICE: PVC AND SILICONE MANUAL RESUSCITATORS DAVID MEDICAL PRODUCTS CO.,LTD 510(k) NO: K051177(TRADITIONAL)
ATTN: DAVID LU PHONE NO : 011 862 162756686 88 FUDA RD. LUDU SE DECISION MADE: 29-AUG-05 TAICANG,SUZHOU,JIANGSU, CHINA 2154510(k) STATEMENT DEVICE: SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0 DAVOL INC., SUB. C.R. BARD, INC. 510(k) NO: K051848(TRADITIONAL)
ATTN: LUCINDA L FOX PHONE NO : 401-463-7000 100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 11-AUG-05 CRANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIONAVIGATOR + DEL MAR REYNOLDS MEDICAL, LTD. 510(k) NO: K051960(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703 377 ROUTE 17 S SE DECISION MADE: 19-AUG-05 HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DELTA PUNCTUM PLUG DELTA LIFE SCIENCE, INC. 510(k) NO: K050851(TRADITIONAL)
ATTN: GEORGE W MURRAY PHONE NO : 901-398-5151 1975 NONCONNAH BLVD. SE DECISION MADE: 19-AUG-05 MEMPHIS, TN 38132 510(k) STATEMENT DEVICE: CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE DENTSPLY INTERNATIONAL 510(k) NO: K052097(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511 221 W. PHILADELPHIA ST.,STE 60 SE DECISION MADE: 12-AUG-05 SUSQUEHANNA COMMERCE CTR. WEST 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K051989(SPECIAL)
ATTN: DENISE LUCIANO PHONE NO : 781-251-2794 249 VANDERBILT AVE. SE DECISION MADE: 05-AUG-05 NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY ASR MODULAR ACETABULAR CUP SYSTEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K040627(TRADITIONAL)
ATTN: NATALIE HECK PHONE NO : 574-371-4905 700 ORTHOPAEDIC DR. SE DECISION MADE: 05-AUG-05 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: SIJF CANNULATED SCREW SYSTEM DEPUY SPINE, INC. 510(k) NO: K051296(TRADITIONAL)
ATTN: SHARON STAROWICZ PHONE NO : 800-227-6633 325 PARAMOUNT DRIVE SE DECISION MADE: 26-AUG-05 RAYNHAM, MA 02780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MELIDE FIBEROPTIC LIGHT DESIGNS FOR VISION, INC. 510(k) NO: K051786(SPECIAL)
ATTN: CYNTHIA J M. NOLTE PHONE NO : 919-859-4207 49 PLAIN STREET SE DECISION MADE: 15-AUG-05 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) DIALYSIS SOLUTIONS, INC. 510(k) NO: K050827(TRADITIONAL)
ATTN: MARCY MACDONALD PHONE NO : 847-279-7740 616 HEATHROW DRIVE SE DECISION MADE: 22-AUG-05 LINCOLNSHIRE, IL 60069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30 DIOMED, LTD. 510(k) NO: K051996(SPECIAL)
ATTN: TIM PHIPPS PHONE NO : 441 223 729314 CAMBRIDGE RESEARCH PARK SE DECISION MADE: 18-AUG-05 CAMBRIDGE, UNITED KINGDOM CB5 9TE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPLASH! IMPRESSION MATERIAL DEVICE DISCUS DENTAL INC. 510(k) NO: K052090(TRADITIONAL)
ATTN: SUZANNE RIDGWAY PHONE NO : 310-845-8339 8550 HIGUERA ST. SE DECISION MADE: 05-AUG-05 CULVER CITY, CA 90232 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SILENT PARTNER SERIES OSA APPLIANCES DREAMWRX DENTAL LABORATORY 510(k) NO: K051014(ABBREVIATED)
ATTN: NICOLAAS BESSELING PHONE NO : 949-466-7472 1911 COLORADO BLVD. SE DECISION MADE: 09-AUG-05 LOS ANGELES, CA 90041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMOTE CARE E.CARE SOLUTIONS, INC. 510(k) NO: K050234(TRADITIONAL)
ATTN: CONSTANCE G BUNDY PHONE NO : 763-574-1976 6740 RIVERVIEW TERRACE SE DECISION MADE: 25-AUG-05 MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIVAS DUAL PLEASURE MALE LATEX CONDOM EAGLE TWE, INC. 510(k) NO: K051273(ABBREVIATED)
ATTN: BILL TAFFS PHONE NO : 678-937-0571 2090 TUCKER INDUSTRIAL ROAD SE DECISION MADE: 19-AUG-05 SUITE A-5 510(k) SUMMARY AVAILABLE FROM FDA TUCKER, GA 30084 DEVICE: BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE ED. GEISTLICH SOEHNE AG FUER CHEMI510(k) NO: K050446(TRADITIONAL)
ATTN: PETER S REICHERTZ PHONE NO : 202-408-9222 1301 K STREET NW SE DECISION MADE: 09-AUG-05 SUITE 600 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM EDWARDS LIFESCIENCES, LLC. 510(k) NO: K052132(SPECIAL)
ATTN: KEVIN DRISKO PHONE NO : 949-250-2416 ONE EDWARDS WAY SE DECISION MADE: 24-AUG-05 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO LYSUS INFUSION SYSTEM EKOS CORP. 510(k) NO: K052071(SPECIAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-482-1108 22030 20TH AVENUE S.E. SE DECISION MADE: 16-AUG-05 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98021 DEVICE: ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 ELEKTA, INC 510(k) NO: K051932(SPECIAL)
ATTN: PETER STEGAGNO PHONE NO : 770-300-9725 4775 PEACHTREE IND. BLVD SE DECISION MADE: 12-AUG-05 BUILDING 300, SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA NORCROSS, GA 30092 DEVICE: HABIB 4X EMCISION, LTD. 510(k) NO: K051420(TRADITIONAL)
ATTN: NAGY HABIB PHONE NO : 016 28 782537 DU CANE ROAD SE DECISION MADE: 15-AUG-05 LONDON, UNITED KINGDOM W12 0HS 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER ENCORE MEDICAL, INC. 510(k) NO: K052086(SPECIAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 512-834-6298 9800 METRIC BLVD. SE DECISION MADE: 31-AUG-05 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STINGRAY EPIDURAL CATHETER CONNECTOR EPIMED INTERNATIONAL, INC. 510(k) NO: K051171(TRADITIONAL)
ATTN: CHRISTOPHER LAKE PHONE NO : 518-725-0209 141 SAL LANDRIO DR. SE DECISION MADE: 26-AUG-05 CROSSROADS BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA JOHNSTOWN, NY 12095 DEVICE: FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 EPIMED INTERNATIONAL, INC. 510(k) NO: K051860(TRADITIONAL)
ATTN: CHRISTOPHER LAKE PHONE NO : 518-725-0209 141 SAL LANDRIO DR. SE DECISION MADE: 22-AUG-05 CROSSROADS BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA JOHNSTOWN, NY 12095 DEVICE: G-SCAN CERVICAL SPINE COIL ESAOTE, S.P.A. 510(k) NO: K052077(SPECIAL)
ATTN: CARRI GRAHAM PHONE NO : 317-849-1916 7992 CASTLEWAY DRIVE SE DECISION MADE: 16-AUG-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES ETHICON ENDO-SURGERY, INC. 510(k) NO: K051301(TRADITIONAL)
ATTN: KIMBERLY MCCOY PHONE NO : 513-337-7266 4545 CREEK RD. SE DECISION MADE: 30-AUG-05 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSCOPIC APPLICATOR ETHICON INC. 510(k) NO: K051732(TRADITIONAL)
ATTN: PETER CECCHINI PHONE NO : 908-218-2457 ROUTE 22 WEST SE DECISION MADE: 09-AUG-05 SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102 EXCEL TECH. LTD. 510(k) NO: K052111(ABBREVIATED)
ATTN: NICOLE LANDREVILLE PHONE NO : 905 829 5300X388 2568 BRISTOL CIRCLE SE DECISION MADE: 17-AUG-05 OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RT019 INSPIRATORY/EXPIRATORY FILTER FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K050927(TRADITIONAL)
ATTN: RENETA MONEY PHONE NO : 64 9 5740100 15 MAURICE PAYKEL PLACE SE DECISION MADE: 01-AUG-05 P.O. BOX 14-348, PANMURE 510(k) SUMMARY AVAILABLE FROM FDA EAST TAMAKI, AUCKLAND, NEW ZEALAND DEVICE: MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K052058(SPECIAL)
ATTN: CHRISTINE QUENDEZ PHONE NO : 335 499 35380 ZI DE KERNEVEZ-6 RUE NOBEL SE DECISION MADE: 22-AUG-05 QUIMPER, FRANCE 29000 510(k) STATEMENT DEVICE: SILBRONCHO DOUBLE LUMEN TUBE FUJI SYSTEMS CORP. 510(k) NO: K051522(TRADITIONAL)
ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW COURT SE DECISION MADE: 17-AUG-05 MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM FUTUMEDS SDN BHD 510(k) NO: K050575(TRADITIONAL)
ATTN: LEONG PEI PING PHONE NO : 603 806 83128 NO. 3, JALAN PUCHONG, SE DECISION MADE: 15-AUG-05 BATU 12 1/2 510(k) STATEMENT PUCHONG, MALAYSIA 47100 DEVICE: OSTEOCURE RESORBABLE BEAD KIT FUTURA BIOMEDICAL 510(k) NO: K051406(TRADITIONAL)
ATTN: LOUISE M FOCHT PHONE NO : 760-599-1670 990 PARK CENTER DR., SUITE H SE DECISION MADE: 01-AUG-05 VISTA, CA 92081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GC FUJI FIL LC GC AMERICA, INC. 510(k) NO: K051427(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-926-3105 3737 WEST 127TH ST. SE DECISION MADE: 22-AUG-05 ALSIP, IL 60803 510(k) STATEMENT DEVICE: DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEAD GE HEALTHCARE 510(k) NO: K051883(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685 86 PILGRIM ROAD SE DECISION MADE: 05-AUG-05 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYN GE HEALTHCARE 510(k) NO: K051967(TRADITIONAL)
ATTN: JOHN L SCHMIDT PHONE NO : 262-548-4964 3000 N. GRANDVIEW BLVD. SE DECISION MADE: 09-AUG-05 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES GE HEALTHCARE 510(k) NO: K052145(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685 86 PILGRIM ROAD SE DECISION MADE: 23-AUG-05 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTRI GE MEDICAL SYSTEMS F.I. HAIFA 510(k) NO: K051855(TRADITIONAL)
ATTN: ELI WERNER PHONE NO : 972 485 63824 4 HAYOZMA ST. SE DECISION MADE: 02-AUG-05 TIRAT HACARMEL, ISRAEL 30200 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA GE MEDICAL SYSTEMS, LLC 510(k) NO: K052157(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894 3200 N. GRANDVIEW BLVD. SE DECISION MADE: 25-AUG-05 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE OEC ALTITUDE GE OEC MEDICAL SYSTEMS 510(k) NO: K052039(ABBREVIATED)
ATTN: SUSAN SCHMIDT PHONE NO : 801-328-9300 384 WRIGHT BROTHERS DR. SE DECISION MADE: 11-AUG-05 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEN-PROBE APTIMA COMBO 2 ASSAY GEN-PROBE, INC. 510(k) NO: K043224(TRADITIONAL)
ATTN: ALAN MADERAZO PHONE NO : 858-410-8332 10210 GENETIC CENTER DR. SE DECISION MADE: 09-AUG-05 SAN DIEGO, CA 92121-4362 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAV - GENERAL ANAESTHETIC VAPORIZER GENERAL ANAESTHETIC SERVICES LIMIT510(k) NO: K051666(TRADITIONAL)
ATTN: ANDREW JW WALL PHONE NO : 044 015 35609615 INGROW BRIDGE BUSINESS PARK SE DECISION MADE: 23-AUG-05 HALIFAX ROAD 510(k) SUMMARY AVAILABLE FROM FDA KEIGHLEY, WEST YORKSHIRE, UNITED KTHIRD PARTY REVIEW DEVICE: GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING GISH BIOMEDICAL, INC. 510(k) NO: K051606(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 832-285-9423 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 12-AUG-05 HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES GLOBUS MEDICAL INC. 510(k) NO: K052069(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000 303 SCHELL LN. SE DECISION MADE: 17-AUG-05 PHOENIXVILLE, PA 19460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RX ACCUNET EMBOLIC PROTECTION SYSTEM GUIDANT CORPORATION 510(k) NO: K052165(SPECIAL)
ATTN: JULIA ANASTAS PHONE NO : 408-845-2201 3200 LAKESIDE DRIVE SE DECISION MADE: 16-AUG-05 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM GUIDANT CORPORATION 510(k) NO: K052166(SPECIAL)
ATTN: JULIA ANASTAS PHONE NO : 408-845-2201 3200 LAKESIDE DRIVE SE DECISION MADE: 18-AUG-05 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) HARTALEGA SDN BHD 510(k) NO: K051777(TRADITIONAL)
ATTN: KUAN KAM HON PHONE NO : 603 627 42177 9 JALAN KUANG BULAN TAMAN SE DECISION MADE: 12-AUG-05 KEPONG INDUSTRIAL ESTATE 510(k) STATEMENT KUALA LUMPUR, MALAYSIA 52100 DEVICE: HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 IN HOSPIRA, INC. 510(k) NO: K052052(SPECIAL)
ATTN: PATRICIA MELERSKI PHONE NO : 224-212-4880 275 N. FIELD DR., BLDG. H-2 SE DECISION MADE: 24-AUG-05 D-389 510(k) SUMMARY AVAILABLE FROM FDA LAKE FOREST, IL 60045-5045 DEVICE: TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP 510(k) NO: K051380(TRADITIONAL)
ATTN: TIFFANI ROGERS PHONE NO : 201-831-5612 325 CORPORATE DR. SE DECISION MADE: 30-AUG-05 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP 510(k) NO: K052037(SPECIAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581 325 CORPORATE DR. SE DECISION MADE: 05-AUG-05 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FR.O.H. CALCANEUS REPAIR SYSTEM I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTE510(k) NO: K051642(TRADITIONAL)
ATTN: AL LIPPINCOTT PHONE NO : 952-492-5858 3150 E. 200TH ST. SE DECISION MADE: 22-AUG-05 PRIOR LAKE, MN 55372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PILONPLATE WITH ANGULAR STABILITY I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTE510(k) NO: K052011(TRADITIONAL)
ATTN: AL LIPPINCOTT PHONE NO : 952-492-5858 3150 E. 200TH ST. SE DECISION MADE: 10-AUG-05 PRIOR LAKE, MN 55372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CML 1000 ICU MEDICAL, INC. 510(k) NO: K051437(TRADITIONAL)
ATTN: JIM COOMBES PHONE NO : 949-366-2183 951 CALLE AMANECER SE DECISION MADE: 03-AUG-05 SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DVT SCANNER IMAGING SCIENCES INTL., INC. 510(k) NO: K051980(TRADITIONAL)
ATTN: DAVID W COWAN PHONE NO : 215-997-5666 1910 NORTH PENN RD. SE DECISION MADE: 19-AUG-05 HATFIELD, PA 19440 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMUNALYSIS COCAINE ELISA FOR HAIR IMMUNALYSIS CORPORATION 510(k) NO: K050465(TRADITIONAL)
ATTN: MICHAEL VINCENT PHONE NO : 909-482-0840 829 TOWNE CENTER DR. SE DECISION MADE: 04-AUG-05 POMONA, CA 91767 510(k) STATEMENT DEVICE: STARPACS DENTAL INFINITT CO., LTD. 510(k) NO: K051715(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1600 MANCHESTER WAY SE DECISION MADE: 02-AUG-05 CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM INFOPIA CO., LTD 510(k) NO: K051285(TRADITIONAL)
ATTN: EDWARD LETKO PHONE NO : 212-674-3636 304 PARK AVENUE SOUTH SE DECISION MADE: 02-AUG-05 SUITE 218 510(k) SUMMARY AVAILABLE FROM FDA NEW YORK, NY 10010 DEVICE: INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000 INION OY 510(k) NO: K051362(TRADITIONAL)
ATTN: HANNA MARTILA PHONE NO : 358 323 06600 LAAKARINKATU 2 SE DECISION MADE: 04-AUG-05 TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY W INNOVA VISION INC. 510(k) NO: K051129(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488 3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 12-AUG-05 FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTI-AMP DC-POWERED INTELLIGENT HEARING SYSTEMS 510(k) NO: K052060(SPECIAL)
ATTN: EDWARD MISKIEL PHONE NO : 305-668-6102 7356 S.W. 48 ST. SE DECISION MADE: 31-AUG-05 MIAMI, FL 33155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIVER C.E. CATHETER INVATEC INNOVATIVE TECHNOLOGIES, S510(k) NO: K051917(TRADITIONAL)
ATTN: STEPHANIE K ISGRIGG ROBINSONPHONE NO : 763-398-7036 4600 NATHAN LANE NORTH SE DECISION MADE: 08-AUG-05 PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 INVIVO RESEARCH, INC. 510(k) NO: K050399(TRADITIONAL)
ATTN: NEIL BATTISTE PHONE NO : 800-331-3220 12601 RESEARCH PKWY. SE DECISION MADE: 26-AUG-05 ORLANDO, FL 32826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESOLVE OPEN BACK HALO RINGS JEROME MEDICAL 510(k) NO: K051918(SPECIAL)
ATTN: BERNIE TATRO PHONE NO : 856-234-8600 305 HARPER DR. SE DECISION MADE: 17-AUG-05 MOORESTOWN, NJ 08057 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET JMS NORTH AMERICA CORP. 510(k) NO: K051814(SPECIAL)
ATTN: CHONG SWEE CHEAU PHONE NO : 510-888-9093 22320 FOOTHILL BLVD., SE DECISION MADE: 04-AUG-05 SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA HAYWARD, CA 94541 DEVICE: ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TIN JOHNSON & JOHNSON VISION CARE, INC510(k) NO: K051900(SPECIAL)
ATTN: SUSAN MORRIS PHONE NO : 904-443-1828 7500 CENTURION PKWY. SE DECISION MADE: 12-AUG-05 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA JACKSONVILLE, FL 32256 DEVICE: JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, T JOIMAX GMBH 510(k) NO: K051827(TRADITIONAL)
ATTN: KARIN GASTINEAU PHONE NO : 650-504-3903 718 UNIVERSITY AVE., SUITE 116 SE DECISION MADE: 12-AUG-05 LOS GATOS, CA 95032 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 KAPP SURGICAL INSTRUMENT, INC. 510(k) NO: K050655(TRADITIONAL)
ATTN: ALBERT SANTILLI PHONE NO : 216-587-4400 4919 WARRENSVILLE CENTER RD. SE DECISION MADE: 08-AUG-05 CLEVELAND, OH 44128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONDEAL CONTOUR HO SYSTEM KAPP SURGICAL INSTRUMENT, INC. 510(k) NO: K050657(TRADITIONAL)
ATTN: ALBERT SANTILLI PHONE NO : 216-587-4400 4919 WARRENSVILLE CENTER RD. SE DECISION MADE: 08-AUG-05 CLEVELAND, OH 44128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCB/STERIS OR-LIGHT INTERFACE BOX KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K051505(TRADITIONAL)
ATTN: PAUL S LEE PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 11-AUG-05 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KARL STORZ TRANS-NASAL ESOPHAGOSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K051972(TRADITIONAL)
ATTN: YVONNE FERNANDEZ PHONE NO : 310-438-4226 600 CORPORATE POINTE SE DECISION MADE: 15-AUG-05 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAGNODENT PERIO TIP (ACCESSORY) KAVO AMERICA CORPORATION 510(k) NO: K042394(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 02-AUG-05 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIEWSEND MEDICAL SYSTEM KENEI CO., LTD. 510(k) NO: K051586(TRADITIONAL)
ATTN: JENNIFER LI PHONE NO : 703-905-8038 6899 CHURCHILL ROAD SE DECISION MADE: 04-AUG-05 MCLEAN, VA 22101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOBLANKET SURGICAL MESH KENSEY NASH CORP. 510(k) NO: K043259(TRADITIONAL)
ATTN: DEBORAH RACIOPPI PHONE NO : 610-594-4389 55 EAST UWCHLAN AVE. SE DECISION MADE: 15-AUG-05 EXTON, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPLANT KERR DENTAL MATERIALS CENTER 510(k) NO: K050984(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVE. SE DECISION MADE: 11-AUG-05 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESORB-X SF KLS-MARTIN L.P. 510(k) NO: K051236(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746 11239 ST. JOHNS INDUSTRIAL SE DECISION MADE: 22-AUG-05 PARKWAY SOUTH 510(k) SUMMARY AVAILABLE FROM FDA JACKSONVILLE, FL 32246 DEVICE: CLEARFIL TRI-S BOND SINGLE DOSE KURARAY MEDICAL KURASHIKI PLANT 510(k) NO: K051796(TRADITIONAL)
ATTN: SATOSHI YAMAGUCHI PHONE NO : 212-986-2230 101 EAST 52ND STREET SE DECISION MADE: 09-AUG-05 26TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA NEW YORK, NY 10022 DEVICE: LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021 LERADO CHINA LIMITED 510(k) NO: K051473(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 31-AUG-05 HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MATRYX INTERFERENCE SCREW LINVATEC BIOMATERIALS, INC. 510(k) NO: K052080(SPECIAL)
ATTN: TUIJA ANNALA PHONE NO : 358 331 65679 P.O. BOX 3 SE DECISION MADE: 25-AUG-05 HERMIANKATU 6-8L 510(k) SUMMARY AVAILABLE FROM FDA TAMPERE, FINLAND FIN-33720 DEVICE: LUMENIS 1000 INTEGRATED SLIT LAMP LUMENIS, INC. 510(k) NO: K052129(TRADITIONAL)
ATTN: KAREN L BAKER PHONE NO : 408-764-3603 2400 CONDENSA ST. SE DECISION MADE: 30-AUG-05 SANTA CLARA, CA 95051-0901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APTUS TITANIUM OSTEOSYNTHESIS SYSTEM MEDARTIS, INC. 510(k) NO: K051567(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235 11234 EL CAMINO REAL, STE 200 SE DECISION MADE: 23-AUG-05 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM MEDARTIS, INC. 510(k) NO: K051946(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235 11234 EL CAMINO REAL, STE 200 SE DECISION MADE: 22-AUG-05 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR MEDCHANNEL, LLC 510(k) NO: K051700(TRADITIONAL)
ATTN: FREDERICK TOBIA PHONE NO : 617-247-9266 55 WORCESTER STREET #3 SE DECISION MADE: 15-AUG-05 BOSTON, MA 02118 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRUG ACCESS SPIKE MEDEGEN MEDICAL MANUFACTURING SERV510(k) NO: K051930(TRADITIONAL)
ATTN: SALVADORE F PALOMARES PHONE NO : 949-463-6146 15 CHEROKEE SE DECISION MADE: 16-AUG-05 TRABUCO CANYON, CA 92679 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR MEDEGEN MEDICAL MANUFACTURING SYST510(k) NO: K051939(TRADITIONAL)
ATTN: TIM TRUITT PHONE NO : 909 390 9080 930 WANNAMAKER AVENUE SE DECISION MADE: 01-AUG-05 ONTARIO, CANADA 91761 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANC MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K051421(TRADITIONAL)
ATTN: KRISTINE LIBERACKI PHONE NO : 800-338-0440 3600 SW 47TH AVENUE SE DECISION MADE: 30-AUG-05 GAINESVILLE, FL 32608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND MEDICAL INSIGHT A/S 510(k) NO: K051809(TRADITIONAL)
ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648 16303 PANORAMIC WAY SE DECISION MADE: 15-AUG-05 SAN LEANDRO, CA 94578 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH MEDLINE 510(k) NO: K051378(TRADITIONAL)
ATTN: JENNIFER MASON PHONE NO : 847-949-2670 ONE MEDLINE PLACE SE DECISION MADE: 03-AUG-05 MUNDLELEIN, IL 60060 510(k) STATEMENT DEVICE: EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR MEDLINE INDUSTRIES, INC. 510(k) NO: K051302(TRADITIONAL)
ATTN: LARA N SIMMONS PHONE NO : 847-578-8072 ONE MEDLINE PL. SE DECISION MADE: 15-AUG-05 MUNDELEIN, IL 60060 510(k) STATEMENT DEVICE: TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K052054(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 16-AUG-05 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K052144(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 31-AUG-05 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K052180(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 23-AUG-05 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K052187(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 22-AUG-05 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 7F SHERPA NX GUIDE CATHETER MEDTRONIC, INC. 510(k) NO: K051846(SPECIAL)
ATTN: FRED L BOUCHER PHONE NO : 978-777-0042 37A CHERRY HILL DR. SE DECISION MADE: 05-AUG-05 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MS 4/5 HEMATOLOGY ANALYZER MELET SCHLOESING LABORATORIES USA 510(k) NO: K050421(ABBREVIATED)
ATTN: JACKIE COLEMAN PHONE NO : 619-596-5859 2030 GILLEPSIE WAY, SUITE 104 SE DECISION MADE: 31-AUG-05 EL CAJON, CA 92020 510(k) STATEMENT DEVICE: MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR MERITS HEALTH PRODUCTS CO., LTD. 510(k) NO: K050430(TRADITIONAL)
ATTN: LEE LEICHTER PHONE NO : 239-768-1118 7690 CAMERON CIRCLE SE DECISION MADE: 04-AUG-05 FORT MYERS, FL 33912 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64 MIDWEST R.F. LLC. 510(k) NO: K051618(TRADITIONAL)
ATTN: DAVID M PETERSON PHONE NO : 262-367-6925 535 NORTON DR. SE DECISION MADE: 02-AUG-05 P.O. BOX 348 510(k) STATEMENT HARTLAND, WI 53029 DEVICE: MILLIKEN SILVER WOUND DRESSINGS MILLIKEN CHEMICAL 510(k) NO: K051445(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 22-AUG-05 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: H12+ HOLTER RECORDER MORTARA INSTRUMENT, INC. 510(k) NO: K050896(TRADITIONAL)
ATTN: HARLAN L VAN MATRE PHONE NO : 414-354-1600 7865 NORTH 86TH ST. SE DECISION MADE: 24-AUG-05 MILWAUKEE, WI 53224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEM 3000 HEAD COIL MR INSTRUMENTS INC. 510(k) NO: K052200(TRADITIONAL)
ATTN: MARK WATSON PHONE NO : 952-746-1435 4802 PARK GLEN ROAD SE DECISION MADE: 19-AUG-05 MINNEAPOLIS, MN 55416 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DOPPLER GUIDED PROCTOSCOPE, MODEL 500H MULTIGON INDUSTRIES, INC. 510(k) NO: K052067(TRADITIONAL)
ATTN: WILLIAM STERN PHONE NO : 914-376-5200 ONE ODELL PLAZA SE DECISION MADE: 29-AUG-05 YONKERS, NY 10701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXIMAX NPB-40 HANDHELD PULSE OXIMETER NELLCOR PURITAN BENNETT, INC. 510(k) NO: K051352(TRADITIONAL)
ATTN: SARAH HARRINGTON PHONE NO : 925-463-4151 4280 HACIENDA DR. SE DECISION MADE: 11-AUG-05 PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO EN-BLOC BIOPSY SYSTEM NEOTHERMIA CORPORATION 510(k) NO: K052246(TRADITIONAL)
ATTN: DAVID JACOBS PHONE NO : 508-655-7820 ONE APPLE HILL SUITE 316 SE DECISION MADE: 22-AUG-05 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV NEW STAR LASERS, INC. 510(k) NO: K051434(TRADITIONAL)
ATTN: DONALD V JOHNSON PHONE NO : 916-677-1900 9085 FOOTHILLS BLVD. SE DECISION MADE: 09-AUG-05 ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPD-STATION SOFTWARE NIDEK, INC. 510(k) NO: K050336(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LN. SE DECISION MADE: 24-AUG-05 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEE-1000A NEUROMASTER NIHON KOHDEN AMERICA, INC. 510(k) NO: K051178(TRADITIONAL)
ATTN: SERRAH NAMINI PHONE NO : 949-580-1555 90 ICON ST. SE DECISION MADE: 17-AUG-05 FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE NIPRO MEDICAL CORP. 510(k) NO: K051574(TRADITIONAL)
ATTN: KAELYN HADLEY PHONE NO : 859-224-8256 1384 COPPERFIELD COURT SE DECISION MADE: 26-AUG-05 LEXINGTON, KY 40514-1268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: O'MY NATURAL LUBRICANT, O'MY NATURAL FLAVORED LUBRICANT O'MY PRODUCTS INCORPORATED 510(k) NO: K042915(TRADITIONAL)
ATTN: ROB LOGAN PHONE NO : 604 990 9700 188 PEMBERTON AVENUE SE DECISION MADE: 31-AUG-05 NORTH VANCOUVER, CANADA V7P 2R5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAREVENT CA AND DRA O-TWO MEDICAL TECHNOLOGIES, INC. 510(k) NO: K051889(SPECIAL)
ATTN: AMMAR AL-DOJAILY PHONE NO : 905 677 9410 7575 KIMBEL ST. SE DECISION MADE: 30-AUG-05 MISSISSAUGA, ONTARIO, CANADA L5S 1510(k) STATEMENT DEVICE: ORS MODEL 6000 ENDOSCOPE HOLDER O.R. SOLUTIONS, INC. 510(k) NO: K051979(SPECIAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 30-AUG-05 CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHR OFFICE OF THE SURGEON GENERAL, U.S510(k) NO: K051794(TRADITIONAL) ATTN: DIANE ULLMAN PHONE NO : 301-619-0317 1436 PORTER STREET SE DECISION MADE: 16-AUG-05 OFFICE OF REGULATORY AFFAIRS 510(k) STATEMENT FORT DETRICK, MD 21702 DEVICE: OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR OLYMPUS AMERICA, INC. 510(k) NO: K051564(TRADITIONAL)
ATTN: BEV HARDING PHONE NO : 972-556-9697 3131 WEST ROYAL LN. SE DECISION MADE: 22-AUG-05 IRVING, TX 75063-3104 510(k) STATEMENT DEVICE: MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K051613(SPECIAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE CENTER DR. SE DECISION MADE: 15-AUG-05 MELVILLE, NY 11747-9058 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY OPTICAL CONNECTION, INC. 510(k) NO: K051095(TRADITIONAL)
ATTN: GAROLD L EDWARDS PHONE NO : 408-265-3860 2091 UPPER SCENIC DRIVE SE DECISION MADE: 16-AUG-05 FELTON, CA 95018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY ORTHOCON, LLC 510(k) NO: K043260(TRADITIONAL)
ATTN: HOWARD SCHRAYER PHONE NO : 732-683-9304 167 STONE HILL ROAD SE DECISION MADE: 12-AUG-05 COLTS NECK, NY 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOSCAN, ORTHOSCAN HD ORTHOSCAN, INC. 510(k) NO: K051754(TRADITIONAL)
ATTN: ARLEN ISSETTE PHONE NO : 480-503-8010 8585 E HARTFORD DRIVE SE DECISION MADE: 09-AUG-05 SCOTTSDALE, AZ 85255 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03 OX-GEN INC. 510(k) NO: K033863(TRADITIONAL)
ATTN: FRANK FOSELLA PHONE NO : 208-336-0773 PO BOX 5867 SE DECISION MADE: 22-AUG-05 BOISE, ID 83702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH PEGASUS BIOLOGICS, INC. 510(k) NO: K043388(TRADITIONAL)
ATTN: MUIR S MEINHOLD PHONE NO : 949-280-1698 10 PASTEUR ST. SE DECISION MADE: 05-AUG-05 SUITE 150 510(k) STATEMENT IRVINE, CA 92618 DEVICE: PENUMBRA ASPIRATION PUMP, MODEL 115V PENUMBRA, INC. 510(k) NO: K051758(TRADITIONAL)
ATTN: THERESA B BRANDNER-ALLEN PHONE NO : 510-618-3200 2401 MERCED ST., SUITE 200 SE DECISION MADE: 17-AUG-05 SAN LEANDRO, CA 94577 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS 12-LEAD ALGORITHM PHILIPS MEDICAL SYSTEMS 510(k) NO: K052049(SPECIAL)
ATTN: SONGHUA ZHANG PHONE NO : 978-659-7319 3000 MINUTEMAN RD. SE DECISION MADE: 26-AUG-05 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACHIEVA 1.5T & INERA 1.5T FAMILY PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K052013(TRADITIONAL)
ATTN: LYNN T HARMER PHONE NO : 425-487-7312 22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 02-AUG-05 P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98041-8431 THIRD PARTY REVIEW DEVICE: VTRAC EXCIMER LAMP SYSTEM PHOTO MEDEX, INC. 510(k) NO: K051428(TRADITIONAL)
ATTN: BOB ROSE PHONE NO : 760-602-3300 2431 IMPALA DR. SE DECISION MADE: 09-AUG-05 CARLSBAD, CA 92008-7227 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNILUX REVIVE AND OMNILUX PLUS PHOTO THERAPEUTICS LIMITED 510(k) NO: K050216(TRADITIONAL)
ATTN: STEVE HUTSON PHONE NO : 441 619 255615 STATION HOUSE SE DECISION MADE: 09-AUG-05 STAMFORD NEW ROAD 510(k) SUMMARY AVAILABLE FROM FDA ALTRINCHAM, CHESHIRE, UNITED KINGDOM WA14 1EP DEVICE: POLYTECH PULMONARY FUNCTION FILTER POLYTECHNIC RESOURCES, INC. 510(k) NO: K042758(TRADITIONAL)
ATTN: TIMOTHY BYRD PHONE NO : 410-391-4700 1107 MIDDLE RIVER ROAD SE DECISION MADE: 29-AUG-05 SUITE B-1 510(k) STATEMENT BALTIMORE, MD 21220 DEVICE: MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH PROXY BIOMEDICAL LTD. 510(k) NO: K052100(SPECIAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035 P.O. BOX 560 SE DECISION MADE: 11-AUG-05 STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVISO OPHTHALMIC ULTRASOUND SYSTEM QUANTEL MEDICAL 510(k) NO: K051851(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703 377 ROUTE 17 SOUTH SE DECISION MADE: 03-AUG-05 HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUILL SYNTHETIC ABSORBABLE BARBED SUTURE QUILL MEDICAL, INC. 510(k) NO: K051609(TRADITIONAL)
ATTN: LOIS V SMART PHONE NO : 919-806-1961 2505 MERIDIAN PKWY. SE DECISION MADE: 04-AUG-05 SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA RESEARCH TRIANGLE PARK, NC 27713 DEVICE: MULTIPLE EROZONE BODYGLIDE FLUID, EROZONE BODYGLIDE GEL, EROZONE R & K INTERNATIONAL COSMETICS 510(k) NO: K040428(TRADITIONAL)
ATTN: GARYN L LOTRIDGE PHONE NO : 202-824-1440 1020 19TH STREET NW SE DECISION MADE: 09-AUG-05 SUITE 400 510(k) STATEMENT WASHINGTON, DC 20036 DEVICE: MODIFICATION TO ABL800 FLEX RADIOMETER MEDICAL APS 510(k) NO: K050869(SPECIAL)
ATTN: MARK A HELLER PHONE NO : 202-663-6005 1455 PENNSYLVANIA AVENUE N.W. SE DECISION MADE: 11-AUG-05 WILLARD OFFICE BUILDING 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20004 DEVICE: RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH B RADIONICS, A DIVISION OF TYCO HEAL510(k) NO: K051947(TRADITIONAL)
ATTN: KEVIN J O'CONNELL PHONE NO : 781-565-1227 22 TERRY AVE. SE DECISION MADE: 22-AUG-05 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES REGENERATION TECHNOLOGIES, INC. 510(k) NO: K051615(TRADITIONAL)
ATTN: CARRIE HARTILL PHONE NO : 386-418-8888 11621 RESEARCH CIR. SE DECISION MADE: 15-AUG-05 P.O. BOX 2650 510(k) SUMMARY AVAILABLE FROM FDA ALACHUA, FL 32616-2650 DEVICE: BIOGEL LATEX STERILE POWDER-FREE GLOVE REGENT MEDICAL AMERICAS, LLC 510(k) NO: K050899(TRADITIONAL)
ATTN: KATHLEEN HARRIS PHONE NO : 678-250-7900 3585 ENGINEERING DR, STE 250 SE DECISION MADE: 12-AUG-05 NORCROSS, GA 30092 510(k) STATEMENT DEVICE: VPAP ADAPT RESMED LTD. 510(k) NO: K051364(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238 14040 DANIELSON ST. SE DECISION MADE: 16-AUG-05 POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INNER-LOCK INTRODUCER SHEATH REX MEDICAL 510(k) NO: K051468(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD. SE DECISION MADE: 04-AUG-05 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: CUTANEOUS ELECTRODE RHYTHMLINK INTERNATIONAL, LLC 510(k) NO: K052188(TRADITIONAL)
ATTN: JAMES M MEWBORNE PHONE NO : 803-252-1222 917 BROOKWOOD DR. SE DECISION MADE: 23-AUG-05 COLUMBIA, SC 29201 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS ROCHE DIAGNOSTICS 510(k) NO: K051376(TRADITIONAL)
ATTN: JENNIFER TRIBBETT PHONE NO : 317-521-3742 9115 HAGUE ROAD SE DECISION MADE: 23-AUG-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C ROCHE DIAGNOSTICS 510(k) NO: K052101(ABBREVIATED)
ATTN: THERESA M AMBROSE PHONE NO : 317-521-3723 9115 HAGUE ROAD SE DECISION MADE: 26-AUG-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO ROCHE DIAGNOSTICS CORP. 510(k) NO: K051890(SPECIAL)
ATTN: KAY A TAYLOR PHONE NO : 317-521-3544 9115 HAGUE RD. SE DECISION MADE: 04-AUG-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IRON STANDARD ROCHE DIAGNOSTICS CORP. 510(k) NO: K052002(TRADITIONAL)
ATTN: CORINA HARPER PHONE NO : 317-521-3831 9115 HAGUE RD. SE DECISION MADE: 22-AUG-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLIVASURE SCANDINAVIAN FORMULAS, INC. 510(k) NO: K051409(TRADITIONAL)
ATTN: CATHERINE P PEKLAK PHONE NO : 215-453-2507 140 EAST CHURCH ST. SE DECISION MADE: 08-AUG-05 SELLERSVILLE, PA 18960 510(k) STATEMENT DEVICE: BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM SCHILLER AG 510(k) NO: K051368(TRADITIONAL)
ATTN: MARKUS BUETLER PHONE NO : 41 41 7664252 ALTGASSE 68 SE DECISION MADE: 09-AUG-05 BAAR, SWITZERLAND CH-6341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRP DIAGNOSTIC ASSAY SENTINEL CH. SRL 510(k) NO: K050836(TRADITIONAL)
ATTN: MARIA E DONAWA PHONE NO : 390 657 82665 PIAZZA ALBANIA 10 SE DECISION MADE: 08-AUG-05 ROME, ITALY 00153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENTINEL IRON LIQUID SENTINEL CH. SRL 510(k) NO: K051115(TRADITIONAL)
ATTN: DAVIDE SPADA PHONE NO : 39 02 3455141 5 VIA PRINCIPE EUGENIO SE DECISION MADE: 25-AUG-05 MILANO, ITALY 20155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING SHEN WEI (USA), INC. 510(k) NO: K051683(TRADITIONAL)
ATTN: STANLEY DUAN PHONE NO : 510-429-8692 33278 CENTRAL AVE. #102 SE DECISION MADE: 01-AUG-05 UNION CITY, CA 94587 510(k) STATEMENT DEVICE: DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K052113(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 09-AUG-05 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES WHITE (NON-COLORED) SHIJIAZHUANG WONDER PLASTIC CO., L510(k) NO: K051923(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 RM 1606 BLDG. 1. JIANXIANGYUAN SE DECISION MADE: 16-AUG-05 NO. 209 BEI SI HUAN ZHONG RD 510(k) SUMMARY AVAILABLE FROM FDA HAIDIAN DISTRICT BEIJING, CHINA 100083 DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED SHIJIAZHUANG WONDER PLASTIC CO., L510(k) NO: K051935(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 RM 1606 BLDG. 1. JIANXIANGYUAN SE DECISION MADE: 02-AUG-05 NO. 209 BEI SI HUAN ZHONG RD 510(k) SUMMARY AVAILABLE FROM FDA HAIDIAN DISTRICT BEIJING, CHINA 100083 DEVICE: BEAUTIFIL FLOW SHOFU DENTAL CORP. 510(k) NO: K051818(TRADITIONAL)
ATTN: DAVID P MORAIS PHONE NO : 760-736-3277 1225 STONE DR. SE DECISION MADE: 03-AUG-05 SAN MARCOS, CA 92078 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO CIRCULATION SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K052029(TRADITIONAL)
ATTN: RUEDIGER KOERNER PHONE NO : 49 919 1189355 SIEMENSSTRASSE 1 SE DECISION MADE: 09-AUG-05 FORCHHEIM, GERMANY D 91301 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K052021(SPECIAL)
ATTN: ISKRA MRAKOVIC PHONE NO : 650-694-5004 1230 SHOREBIRD WAY SE DECISION MADE: 17-AUG-05 P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA MOUNTAIN VIEW, CA 94039-7393 DEVICE: NUBIC SPINAL IMPLANT SIGNUS MEDICAL LLC. 510(k) NO: K052096(SPECIAL)
ATTN: TRACY L GRAY PHONE NO : 763-588-9873 4050 OLSON MEMORIAL HIGHWAY SE DECISION MADE: 16-AUG-05 SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55422 DEVICE: SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES SILVESTRIN FABRIS S.R.L. 510(k) NO: K050183(TRADITIONAL)
ATTN: FEDERICO SILVESTRIN PHONE NO : 54 11 49250015 AV. LA PLATA 1560 SE DECISION MADE: 16-AUG-05 BUENOS AIRES, ARGENTINA 1250 510(k) STATEMENT DEVICE: SBI K-WIRES SMALL BONE INNOVATIONS, LLC 510(k) NO: K051605(TRADITIONAL)
ATTN: DONALD GUTHNER PHONE NO : 212-583-0250 1711 S. PENNSYLVANIA AVENUE SE DECISION MADE: 10-AUG-05 MORRISVILLE, PA 19067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MO SMITHS MEDICAL INTERNATIONAL, LTD.510(k) NO: K051322(TRADITIONAL)
ATTN: DONALD ALEXANDER PHONE NO : 262-542-3100 N7 W22025 JOHNSON DRIVE SE DECISION MADE: 05-AUG-05 WAUKESHA, WI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARLO SURGICAL GOWN SOFILM TECHNOLOGY CO., LTD. 510(k) NO: K051426(TRADITIONAL)
ATTN: JEFFRY O STULL PHONE NO : 512 288 8272 622 SEC. 3 ANKANG ROAD SE DECISION MADE: 02-AUG-05 HISNTIEN CITY 510(k) SUMMARY AVAILABLE FROM FDA TAIPEI COUNTY 231, CHINA (TAIWAN) DEVICE: UGYTEX SUAL KNIT MESH SOFRADIM PRODUCTION 510(k) NO: K051503(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVENUE SE DECISION MADE: 05-AUG-05 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS SONOSCAPE COMPANY LIMITED 510(k) NO: K052042(TRADITIONAL)
ATTN: BOB LEIKER PHONE NO : 925-556-1302 7263 CRONIN CIRCLE SE DECISION MADE: 09-AUG-05 DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES) SONOSITE,INC. 510(k) NO: K052109(TRADITIONAL)
ATTN: DAINA L GRAHAM PHONE NO : 425-951-1295 21919 30TH DRIVE SE. SE DECISION MADE: 11-AUG-05 BOTHELL, WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODEL SR-115 PORTABLE X-RAY SYSTEM SOURCE-RAY, INC. 510(k) NO: K052001(TRADITIONAL)
ATTN: RAY MANEZ PHONE NO : 631-244-8200 167 KEYLAND CT. SE DECISION MADE: 11-AUG-05 BOHEMIA, NY 11716 510(k) STATEMENT DEVICE: 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 SPECTRANETICS CORP. 510(k) NO: K043465(TRADITIONAL)
ATTN: ADRIAN E ELFE PHONE NO : 719-633-8333 96 TALAMINE CT. SE DECISION MADE: 18-AUG-05 COLORADO SPRINGS, CO 80907-5159 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30 SPECTRX, INC. 510(k) NO: K051045(SPECIAL)
ATTN: WILLIAM M VONDERSMITH PHONE NO : 770-242-8723 4955 AVALON RIDGE PARKWAY SE DECISION MADE: 02-AUG-05 NORCROSS, GA 30071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSITE VERISMO SOFTWARE ST. JUDE MEDICAL 510(k) NO: K051840(TRADITIONAL)
ATTN: KAREN MCKELVEY PHONE NO : 651-523-6900 1350 ENERGY LANE. SUITE 110 SE DECISION MADE: 15-AUG-05 ST. PAUL, MN 55108 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CD-CHEX PLUS BC STRECK 510(k) NO: K051633(TRADITIONAL)
ATTN: CAROL THOMPSON PHONE NO : 402-537-5313 7002 SOUTH 109TH ST. SE DECISION MADE: 16-AUG-05 OMAHA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IQ BODY FLUIDS CONTROL STRECK 510(k) NO: K051706(TRADITIONAL)
ATTN: MARK LEWALLEN PHONE NO : 402-537-5215 7002 SOUTH 109TH ST. SE DECISION MADE: 17-AUG-05 OMAHA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: XIA STAINLESS STEEL SYSTEM STRYKER SPINE 510(k) NO: K051973(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145 2 PEARL COURT SE DECISION MADE: 18-AUG-05 ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL X SYSMEX AMERICA, INC. 510(k) NO: K051199(TRADITIONAL)
ATTN: NINA M GAMPERLING PHONE NO : 847-996-4675 ONE NELSON C. WHITE PARKWAY SE DECISION MADE: 08-AUG-05 MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEVER TD-3018A BLOOD PRESSURE MONITOR TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K051703(TRADITIONAL)
ATTN: SHU-MEI WU PHONE NO : 886 2 66358080 4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 12-AUG-05 SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEVER CHEK TD-4225, MODEL TD-4225 TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K051854(SPECIAL)
ATTN: SHU-MEI WU PHONE NO : 886 266 358080 4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 05-AUG-05 SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESS TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K051936(SPECIAL)
ATTN: SHU-MEI WU PHONE NO : 886 266 358080 4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 08-AUG-05 SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: DIRECT LDL CHOLESTEROL, MODEL L530-60H TECO DIAGNOSTICS 510(k) NO: K051121(TRADITIONAL)
ATTN: JIAN VAECHES PHONE NO : 714-693-7788 1268 NORTH LAKEVIEW AVE. SE DECISION MADE: 08-AUG-05 ANAHEIM, CA 92807 510(k) STATEMENT DEVICE: HEMOGLOBIN A1C REAGENT SET TECO DIAGNOSTICS 510(k) NO: K051200(TRADITIONAL)
ATTN: JIAN VAECHES PHONE NO : 714-693-7788 1268 NORTH LAKEVIEW AVE. SE DECISION MADE: 08-AUG-05 ANAHEIM, CA 92807 510(k) STATEMENT DEVICE: URITEK-720+ URINE ANALYZER TECO DIAGNOSTICS 510(k) NO: K051526(TRADITIONAL)
ATTN: STEPHANIE LOW PHONE NO : 714-693-7788 1268 NORTH LAKEVIEW AVE. SE DECISION MADE: 16-AUG-05 ANAHEIM, CA 92807 510(k) STATEMENT DEVICE: ORTHOMEND TEI BIOSCIENCES INC. 510(k) NO: K051766(ABBREVIATED)
ATTN: KENNETH JAMES PHONE NO : 617-268-1616 7 ELKINS ST. SE DECISION MADE: 11-AUG-05 BOSTON, MA 02127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MO TENACORE HOLDINGS, INC. 510(k) NO: K043075(TRADITIONAL)
ATTN: BRAND CASO PHONE NO : 714-444-4643 647 EAST YOUNG STREET SE DECISION MADE: 18-AUG-05 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH TERUMO MEDICAL CORP. 510(k) NO: K051601(TRADITIONAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7213 950 ELKTON BLVD. SE DECISION MADE: 04-AUG-05 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERUMO SYRINGE WITH/WITHOUT NEEDLE TERUMO MEDICAL CORP. 510(k) NO: K052034(SPECIAL)
ATTN: BARBARA SMITH PHONE NO : 410-392-7241 125 BLUE BALL RD. SE DECISION MADE: 16-AUG-05 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVADER UGT1A1 MOLECULAR ASSAY THIRD WAVE TECHNOLOGIES, INC. 510(k) NO: K051824(TRADITIONAL)
ATTN: SAM RUA PHONE NO : 608-204-2966 502 SOUTH ROSA RD. SE DECISION MADE: 18-AUG-05 MADISON, WI 53719-1256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESTELITE FLOW QUICK TOKUYAMA DENTAL CORPORATION 510(k) NO: K051808(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070 1425 K STREET, N.W. SUITE 1100 SE DECISION MADE: 08-AUG-05 WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LS TRIAGE MEDICAL, INC. 510(k) NO: K051949(SPECIAL)
ATTN: GAYLE HIROTA PHONE NO : 949-472-0006 13700 ALTON PKWY., SUITE 160 SE DECISION MADE: 05-AUG-05 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROPULSE PHACOEMULSIFICATION SYSTEM TRILLIUM MEDICAL, INC. 510(k) NO: K051186(ABBREVIATED)
ATTN: MICHAEL H CURTIS PHONE NO : 360-286-1341 P.O. BOX 2601 SE DECISION MADE: 18-AUG-05 POULSBO, WA 98370 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU TRIPATH IMAGING, INC. 510(k) NO: K051282(TRADITIONAL)
ATTN: BRYAN J TUCKER PHONE NO : 919-206-7101 4025 STIRRUP CREEK DRIVE SE DECISION MADE: 16-AUG-05 STE. 400 510(k) STATEMENT DURHAM, NC 27703 DEVICE: OPTIMA SPINAL SYSTEM U&I CORP. 510(k) NO: K051971(SPECIAL)
ATTN: BETTY LIM PHONE NO : +82 318 520102X254 529-1 YONGHYUN-DONG SE DECISION MADE: 04-AUG-05 EUIJUNGBU, KYUNGGI-DO, REPUBLIC OF510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLONIC AND ENEMA NOZZLE ULTIMATE CONCEPTS, INC. 510(k) NO: K051344(SPECIAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 18-AUG-05 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRAPACS ULTRARAD CORPORATION 510(k) NO: K051813(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 214-262-4209 1600 MANCHESTER WAY SE DECISION MADE: 15-AUG-05 CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U2 ACETABULAR COMPONENT UNITED ORTHOPEDIC CORP. 510(k) NO: K050262(TRADITIONAL)
ATTN: GENE HUANG PHONE NO : 886 357 73351 EX28 57 PARK AVE. 2, SCIENCE PARK SE DECISION MADE: 15-AUG-05 HSINCHU, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U1 HIP SYSTEM - BIPOLAR UNITED ORTHOPEDIC CORP. 510(k) NO: K050269(TRADITIONAL)
ATTN: GENE HUANG PHONE NO : 886 357 73351 EX28 57 PARK AVE. 2, SCIENCE PARK SE DECISION MADE: 29-AUG-05 HSINCHU, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UROPLASTY RIGID ENDOSCOPIC NEEDLE UROPLASTY, INC. 510(k) NO: K051905(TRADITIONAL)
ATTN: MICHAEL MORRELL PHONE NO : 612-383-1180 2718 SUMMER ST. NE SE DECISION MADE: 29-AUG-05 MINNEAPOLIS, MN 55413-2820 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR VALLEYLAB 510(k) NO: K051644(TRADITIONAL)
ATTN: HERBERT VINSON PHONE NO : 303-530-6469 5920 LONGBOW DR. SE DECISION MADE: 11-AUG-05 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT VANCOUVER BIOTECH LTD. 510(k) NO: K050644(TRADITIONAL)
ATTN: ANDREW LEE PHONE NO : 604 325 4602 9121 SHAUGHNESSY ST. SE DECISION MADE: 17-AUG-05 VANCOUVER, CANADA V6P 6R9 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER VASCULAR SOLUTIONS, INC. 510(k) NO: K051193(TRADITIONAL)
ATTN: SARA L COON PHONE NO : 763-656-4399 6464 SYCAMORE COURT NORTH SE DECISION MADE: 08-AUG-05 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40 VIDENT 510(k) NO: K052130(SPECIAL)
ATTN: BARBARA J LEWANDOWSKI PHONE NO : 714-961-6200 3150 EAST BIRCH ST. SE DECISION MADE: 15-AUG-05 BREA, CA 92821 510(k) STATEMENT DEVICE: HIPPOCAMPE WHEELCHAIR VIPAMAT TECHNOLOGIE 510(k) NO: K051709(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN STERRT SE DECISION MADE: 15-AUG-05 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT VIRAMED BIOTECH AG 510(k) NO: K051071(TRADITIONAL)
ATTN: BARRY E MENEFEE PHONE NO : 760-594-7285 1730 SOUTH DITMAR STREET SE DECISION MADE: 11-AUG-05 OCEANSIDE, CA 92054 510(k) STATEMENT DEVICE: BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT VIRAMED BIOTECH AG 510(k) NO: K051169(TRADITIONAL)
ATTN: BARRY E MENEFEE PHONE NO : 760-594-7285 1730 SOUTH DITMAR STREET SE DECISION MADE: 11-AUG-05 OCEANSIDE, CA 92054 510(k) STATEMENT DEVICE: VITALCARE I.V. ADMINISTRATION SET VITALCARE GROUP, INC. 510(k) NO: K050906(TRADITIONAL)
ATTN: MICHAEL MCAVENIA PHONE NO : 305-620-4007 8935 NW 27TH STREET SE DECISION MADE: 23-AUG-05 MIAMI, FL 33172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VOLCANO CORPORATION 510(k) NO: K051337(SPECIAL)
ATTN: LORRY HUFFMAN PHONE NO : 916-638-9404 2870 KILGORE ROAD SE DECISION MADE: 18-AUG-05 RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 VOLCANO CORPORATION 510(k) NO: K051920(SPECIAL)
ATTN: MICHELLE J BADAL PHONE NO : 916-861-0287 2870 KILGORE RD. SE DECISION MADE: 19-AUG-05 RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VYGON NUTRILINE CATHETERS VYGON CORP. 510(k) NO: K051690(TRADITIONAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300 2495 GENERAL ARMISTEAD AVE SE DECISION MADE: 19-AUG-05 NORRISTOWN, PA 19403 510(k) STATEMENT DEVICE: WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST W.H.P.M., INC. 510(k) NO: K051841(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808 163 CABOT ST. SE DECISION MADE: 22-AUG-05 BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNI SPHINCTEROTOME WILSON-COOK MEDICAL, INC. 510(k) NO: K052051(SPECIAL)
ATTN: MARGE WALLS-WALKER PHONE NO : 800-245-4707 4900 BETHANIA STATION RD. & SE DECISION MADE: 05-AUG-05 5951 GRASSY CREEK BLVD. 510(k) SUMMARY AVAILABLE FROM FDA WINSTON-SALEM, NC 27105 DEVICE: CONSERVE TOTAL FEMORAL HEAD WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K051348(TRADITIONAL)
ATTN: THERESA LEISTER PHONE NO : 901-867-9971 5677 AIRLINE RD. SE DECISION MADE: 19-AUG-05 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHARLOTTE SMALL MTP FUSION PLATE WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K051884(SPECIAL)
ATTN: WESLEY L REED PHONE NO : 901-867-4701 5677 AIRLINE RD. SE DECISION MADE: 05-AUG-05 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHARLOTTE COMPRESSION PLATE WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K051908(SPECIAL)
ATTN: WESLEY L REED PHONE NO : 901-867-4120 5677 AIRLINE RD. SE DECISION MADE: 10-AUG-05 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFEMUR RENAISSANCE HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K051995(SPECIAL)
ATTN: THERESA LEISTER PHONE NO : 901-867-4143 5677 AIRLINE RD. SE DECISION MADE: 22-AUG-05 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRICOT BLOOD PRESSURE CUFF YA HORNG ELECTRONIC CO., LTD. 510(k) NO: K051539(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 05-AUG-05 HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, YA HORNG ELECTRONIC CO., LTD. 510(k) NO: K051862(TRADITIONAL)
ATTN: JEN KEN-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 23-AUG-05 HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMLUCK, YA HORNG YA HORNG ELECTRONIC CO., LTD. 510(k) NO: K051863(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 19-AUG-05 HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE Z-MEDICA CORPORATION 510(k) NO: K051955(SPECIAL)
ATTN: ROBERT V PACKARD PHONE NO : 203-294-0000 4 FAIRFIELD BLVD. SE DECISION MADE: 10-AUG-05 WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM ZYCARE 510(k) NO: K050821(TRADITIONAL)
ATTN: STEVE D HOLDAWAY PHONE NO : 919-419-7228 3804 SWEETEN CREEK RD. SE DECISION MADE: 16-AUG-05 CHAPEL HILL, NC 27514 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 292 TOTAL WITH SUMMARIES 256 TOTAL WITH STATEMENTS 36
Updated September 6, 2005
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