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510(k)s Final Decisions Rendered for August 2005 |
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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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