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510(k)s Final Decisions Rendered for May 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-MAY-2005 THROUGH 31-MAY-2005
DEVICE: XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
ABBOTT LABORATORIES 510(k) NO: K050534(SPECIAL)
ATTN: JOANNA DEVELTER PHONE NO : 650-474-3331
400 SAGINAW DRIVE SE DECISION MADE: 20-MAY-05
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS
ABBOTT LABORATORIES INC 510(k) NO: K051213(SPECIAL)
ATTN: ANDREA RUTH PHONE NO : 510-749-6343
1360 SOUTH LOOP ROAD SE DECISION MADE: 27-MAY-05
ALAMEDA, CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON +/- MIDSTREAM PREGNANCY TEST
ACON LABORATORIES, INC. 510(k) NO: K050546(SPECIAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 20-MAY-05
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE
ACON LABORATORIES, INC. 510(k) NO: K050593(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 06-MAY-05
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM
ACUMED LLC 510(k) NO: K051083(TRADITIONAL)
ATTN: ED BOEHMER PHONE NO : 503-627-9957
5885 NW CORNELIUS PASS RD. SE DECISION MADE: 12-MAY-05
HILLSBORO, OR 97124-9432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANS SCS ACCESSORY KIT
ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K050922(SPECIAL)
ATTN: DANIELLE ALARCON PHONE NO : 972-309-8559
6901 PRESTON RD. SE DECISION MADE: 18-MAY-05
PLANO, TX 75024 510(k) STATEMENT
DEVICE: STERRAD NX CHALLENGE PACK
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K042450(TRADITIONAL)
ATTN: JOSEPH M ASCENZI PHONE NO : 949-453-6352
33 TECHNOLOGY DR. SE DECISION MADE: 12-MAY-05
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABC 2 SCREW
AESCULAP, INC. 510(k) NO: K050813(SPECIAL)
ATTN: KATHY A RACOSKY PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 04-MAY-05
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCENT
AIR TECHNIQUES, INC. 510(k) NO: K050693(TRADITIONAL)
ATTN: JOSEPH CAREY PHONE NO : 516-433-7676
70 CANTIAGUE ROCK RD. SE DECISION MADE: 26-MAY-05
HICKSVILLE, NY 11801 510(k) STATEMENT
DEVICE: LAGUNA PEDICLE SCREW SYSTEM
ALLEZ SPINE, LLC 510(k) NO: K050060(TRADITIONAL)
ATTN: HARTMUT LOCH PHONE NO : 619-885-7733
2009 FREDA LANE SE DECISION MADE: 04-MAY-05
CARDIFF, CA 92007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMT NANOCATH
AMERICAN MEDICAL TECHNOLOGIES, INC510(k) NO: K050557(TRADITIONAL)
ATTN: MICHAEL RENICK PHONE NO : 561-863-4183
1211 WEST 13TH ST. SE DECISION MADE: 27-MAY-05
RIVIERA BEACH, FL 33404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSINO I.V. START KIT
AMSINO INTERNATIONAL, INC. 510(k) NO: K050654(TRADITIONAL)
ATTN: CHING CHING SEAH PHONE NO : 909-626-5888
855 TOWNE CENTER DRIVE SE DECISION MADE: 02-MAY-05
POMONA, CA 91767 510(k) STATEMENT
DEVICE: AMSINO SUTURE REMOVAL KIT
AMSINO INTERNATIONAL, INC. 510(k) NO: K050656(TRADITIONAL)
ATTN: CHING CHING SEAH PHONE NO : 909-626-5888
855 TOWNE CENTER DRIVE SE DECISION MADE: 02-MAY-05
POMONA, CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
ANGIODYNAMICS, INC. 510(k) NO: K051060(SPECIAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 26-MAY-05
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REP
ANGIOLOGICA B. M. SRL 510(k) NO: K043191(TRADITIONAL)
ATTN: ROBERTO MANCA PHONE NO : 39 038 2556616
4, VIA GIOVANNI XXIII SE DECISION MADE: 16-MAY-05
SAN MARTINO SICCOMARIO, PAVIA, ITA510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX BIO-PIN
ARTHREX, INC. 510(k) NO: K050259(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 27-MAY-05
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX TAK FAMILY
ARTHREX, INC. 510(k) NO: K050749(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 12-MAY-05
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIOSTAR XT
ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K050900(SPECIAL)
ATTN: REINHARD THIEME PHONE NO : 493 641 220174
GOESCHWITZERSTRASSE 51-52 SE DECISION MADE: 16-MAY-05
JENA, GERMANY 07745 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101
ASEPTICO, INC. 510(k) NO: K051077(TRADITIONAL)
ATTN: GRANT RAMALEY PHONE NO : 425-487-3157
8333 216TH ST., S.E. SE DECISION MADE: 03-MAY-05
WOODINVILLE, WA 98072 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER
ASTRA TECH, INC. 510(k) NO: K050874(SPECIAL)
ATTN: BRUCE R MANNING PHONE NO : 508-393-3100
20 MAIN STREET SE DECISION MADE: 05-MAY-05
NORTHBOROUGH, MA 01532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATA HCM MONOPLACE HYPERBARIC SYSTEM
ATA HYPERBARIC CHAMBER MANUFACTURI510(k) NO: K040145(TRADITIONAL)
ATTN: HUMPHREY KILLAM PHONE NO : 888 881 2284
695-ALPHA STREET SE DECISION MADE: 04-MAY-05
VICTORIA, BC, CANADA 510(k) STATEMENT
DEVICE: PAINACEA MODEL XR8 INFRARED HEAT LAMP
ATLANTIS LUMINESCENT PRODUCTS, LLC510(k) NO: K051046(TRADITIONAL)
ATTN: JAMES HARVEY KNAUSS PHONE NO : 832-285-9423
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 10-MAY-05
HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE
ATRION MEDICAL PRODUCTS, INC. 510(k) NO: K043249(TRADITIONAL)
ATTN: DAN CLARK PHONE NO : 256-586-1580
1426 CURT FRANCIS RD. SE DECISION MADE: 25-MAY-05
PO BOX 564 510(k) SUMMARY AVAILABLE FROM FDA
ARAB, AL 35016
DEVICE: ATRIUM ICAST COVERED STENT
ATRIUM MEDICAL CORP. 510(k) NO: K050814(SPECIAL)
ATTN: JOSEPH P PAOLO PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 06-MAY-05
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: E1 MEDICAL FLAT PANEL DISPLAY SYSTEM
BARCOVIEW 510(k) NO: K051201(TRADITIONAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 325 623 3459
35 PRESIDENT KENNEDYPARK SE DECISION MADE: 26-MAY-05
KORTRIJK, BELGIUM 8500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT
BAUSCH & LOMB, INC. 510(k) NO: K050948(ABBREVIATED)
ATTN: ANNE ZAVERTNIK PHONE NO : 585-338-5816
1400 NORTH GOODMAN ST. SE DECISION MADE: 18-MAY-05
ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)
BAXTER HEALTHCARE CORP., BIOSCIENC510(k) NO: K050495(SPECIAL)
ATTN: RON LAGERQUIST PHONE NO : 805-372-3064
ONE BAXTER WAY SE DECISION MADE: 02-MAY-05
WESTLAKE VILLAGE, CA 91362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
BAYER HEALTHCARE, LLC 510(k) NO: K050632(TRADITIONAL)
ATTN: ANDRES HOLLE PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 26-MAY-05
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMM
BECKMAN COULTER, INC. 510(k) NO: K050119(TRADITIONAL)
ATTN: KIM WALKER PHONE NO : 714-961-4912
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 06-MAY-05
P.O. BOX 8000, M/S W-515 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92822-8000
DEVICE: BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP)
BECTON DICKINSON & CO. 510(k) NO: K050780(TRADITIONAL)
ATTN: LINDA DILLON PHONE NO : 303-390-3240
7 LOVETON CIR. SE DECISION MADE: 12-MAY-05
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHO
BECTON, DICKINSON & CO. 510(k) NO: K050865(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 20-MAY-05
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP)
BECTON, DICKINSON & CO. 510(k) NO: K050881(TRADITIONAL)
ATTN: MONICA E GUIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 12-MAY-05
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.031
BECTON, DICKINSON & CO. 510(k) NO: K050946(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 27-MAY-05
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.06
BECTON, DICKINSON & CO. 510(k) NO: K050982(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 24-MAY-05
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT
BEST SANITIZERS, INC. 510(k) NO: K041984(TRADITIONAL)
ATTN: RICHARD M ORMSBEE PHONE NO : 763-551-2689
14605 28TH AVENUE NORTH SE DECISION MADE: 11-MAY-05
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
BIO-RAD LABORATORIES, INC. 510(k) NO: K051072(TRADITIONAL)
ATTN: WILLIAM G GUSTAFSON PHONE NO : 510-741-6114
4000 ALFRED NOBEL DR. SE DECISION MADE: 12-MAY-05
HERCULES, CA 94547 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-0
BIOARRAY SOLUTIONS LTD 510(k) NO: K043067(TRADITIONAL)
ATTN: KEVIN WYCKOFF PHONE NO : 908-226-8200
35 TECHNOLOGY DRIVE SE DECISION MADE: 31-MAY-05
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
WARREN, NJ 07059
DEVICE: QUANTIA A1-AT
BIOKIT S.A. 510(k) NO: K050596(TRADITIONAL)
ATTN: JOAN GUIXER PHONE NO : 011 349 38609000
LLISSA D'AMUNT SE DECISION MADE: 13-MAY-05
BARCELONA, SPAIN 08186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO MBCP
BIOMATLANTE 510(k) NO: K043005(TRADITIONAL)
ATTN: MYRIAM VINCENT PHONE NO : 003 322 8020009
5, RUE EDOUARD BELIN SE DECISION MADE: 03-MAY-05
VIGNEUX DE BRETAGNE, FRANCE 44360 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 GRAM POSITIVE MEROPENEM
BIOMERIEUX, INC. 510(k) NO: K050816(TRADITIONAL)
ATTN: JOLYN TENLLADO PHONE NO : 314-731-8386
595 ANGLUM DR. SE DECISION MADE: 12-MAY-05
HAZELWOOD, MO 63042-2320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
BIOMERIEUX, INC. 510(k) NO: K050976(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695
595 ANGLUM DR. SE DECISION MADE: 23-MAY-05
HAZELWOOD, MO 63042-2320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BALANCE HIP SYSTEM
BIOMET, INC. 510(k) NO: K050251(TRADITIONAL)
ATTN: GARY BAKER PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 27-MAY-05
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RNA1C CONTROL FOR NYCOCARD HBA1C
BIONOSTICS, INC. 510(k) NO: K050961(TRADITIONAL)
ATTN: KATHLEEN STORRO PHONE NO : 978-772-7070
7 JACKSON RD. SE DECISION MADE: 13-MAY-05
DEVENS, MA 01434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPRO TARA FEMORAL RESURFACING COMPONENT
BIOPRO, INC. 510(k) NO: K043542(TRADITIONAL)
ATTN: DAVID MRAK PHONE NO : 810-982-7777
17 SEVENTEENTH ST. SE DECISION MADE: 18-MAY-05
PORT HURON, MI 48060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND M
BIOSCREEN MEDICAL INC. 510(k) NO: K050305(TRADITIONAL)
ATTN: JIMMY LIANG PHONE NO : 570-928-7636
RR I BOX 1045A SE DECISION MADE: 23-MAY-05
MILDRED, PA 18632 510(k) STATEMENT
DEVICE: HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM
BLACKSTONE MEDICAL, INC. 510(k) NO: K050892(SPECIAL)
ATTN: DEAN E CIPORKIN PHONE NO : 413-726-2513
90 BROOKSDALE DR. SE DECISION MADE: 11-MAY-05
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRA-SOFT SV BALLOON DILATATION CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K050389(TRADITIONAL)
ATTN: ANGIE BYLAND PHONE NO : 763-494-2887
TWO SCIMED PLACE SE DECISION MADE: 25-MAY-05
MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS PV
BOSTON SCIENTIFIC CORP. 510(k) NO: K050684(SPECIAL)
ATTN: ROBERT Z PHILLIPS PHONE NO : 510-624-2307
47900 BAYSIDE PARKWAY SE DECISION MADE: 20-MAY-05
FREMONT, CA 94538-6515 510(k) STATEMENT
DEVICE: IPLAN! DIGITAL TEMPLATING
BRAINLAB AG 510(k) NO: K042543(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680
AMMERTHALSTRASSE 8 SE DECISION MADE: 17-MAY-05
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: O-ARM IMAGING SYSTEM
BREAKAWAY IMAGING, LLC 510(k) NO: K050996(ABBREVIATED)
ATTN: WOLFGANG KRULL PHONE NO : 978-952-2900
300 FOSTER STREET SE DECISION MADE: 05-MAY-05
LITTLETON, MA 01460 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSIO
C.R. BARD, INC. 510(k) NO: K050006(TRADITIONAL)
ATTN: DEBORAH L HERRINGTON PHONE NO : 978-323-2216
55 TECHNOLOGY DR. SE DECISION MADE: 27-MAY-05
LOWELL, MA 01851 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERHOHN AND POWERLINE CATHETERS
C.R. BARD, INC. 510(k) NO: K050185(TRADITIONAL)
ATTN: CHRLES MORREALE PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 26-MAY-05
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U-BALLOON DILATION CATHETER
C.R. BARD, INC. 510(k) NO: K050875(TRADITIONAL)
ATTN: JOHN C KNORPP PHONE NO : 770-784-6257
8195 INDUSTRIAL BLVD. SE DECISION MADE: 26-MAY-05
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PMP4 SPIROPRO
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K050853(SPECIAL)
ATTN: NA'AMA OREN PHONE NO : 972 8 9484000
2 PEKERIS ST. SE DECISION MADE: 04-MAY-05
REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIOPAQUE BONE CEMENT
CARDINAL HEALTH 510(k) NO: K043518(TRADITIONAL)
ATTN: SHARON NICHOLS PHONE NO : 847-578-6610
1430 WAUKEGAN RD. SE DECISION MADE: 11-MAY-05
BUILDING KB 510(k) SUMMARY AVAILABLE FROM FDA
MCGAW PARK, IL 60085
DEVICE: INTRABEAM SYSTEM
CARL ZEISS SURGICAL GMBH 510(k) NO: K051055(SPECIAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 23-MAY-05
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELLERATION MIST THERAPY SYSTEM 5.1
CELLERATION, INC. 510(k) NO: K050129(TRADITIONAL)
ATTN: DAVID BREMSETH PHONE NO : 952-224-8704
10250 VALEY VIEW ROAD SE DECISION MADE: 17-MAY-05
SUITE 137 510(k) SUMMARY AVAILABLE FROM FDA
EDEN PRAIRIE, MN 55344
DEVICE: FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVE
CIBA VISION CORPORATION 510(k) NO: K050065(TRADITIONAL)
ATTN: PENNY NORTHCUTT, RAC PHONE NO : 678-415-3214
11440 JOHNS CREEK PARKWAY SE DECISION MADE: 27-MAY-05
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOPPLER-BOX
COMPUMEDICS GERMANY GMGH 510(k) NO: K051085(TRADITIONAL)
ATTN: GEROLD WIDENHORN PHONE NO : 497 731 797690
JOSEF-SCHUETTLER STR. 2 SE DECISION MADE: 05-MAY-05
SINGEN, GERMANY 78224 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CONCENTRIC EMBOLIC PEARLS
CONCENTRIC MEDICAL, INC. 510(k) NO: K050470(TRADITIONAL)
ATTN: JEAN M CAILLOUETTE PHONE NO : 650-938-2100
1380 SHOREBIRD WAY SE DECISION MADE: 06-MAY-05
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
CONMED INTEGRATED SYSTEMS (CMIS) 510(k) NO: K050829(TRADITIONAL)
ATTN: C. JEFF LIPPS PHONE NO : 503-614-1106
1815 NW 169TH PLACE SE DECISION MADE: 06-MAY-05
SUITE 4020 510(k) SUMMARY AVAILABLE FROM FDA
BEAVERTON, OR 97006
DEVICE: LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED
CONMED LINVATEC 510(k) NO: K050923(TRADITIONAL)
ATTN: ELIZABETH PAUL PHONE NO : 727-399-5234
11311 CONCEPT BOULEVARD SE DECISION MADE: 18-MAY-05
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIS DERMAL AUGMENTATION STRAND
COOK BIOTECH, INC. 510(k) NO: K050246(TRADITIONAL)
ATTN: MARK BLEYER PHONE NO : 765-497-3355
1425 INNOVATION PLACE SE DECISION MADE: 19-MAY-05
WEST LAFAYETTE, IN 47906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUNTHER TULIP VENA CAVA FILTER SET
COOK, INC. 510(k) NO: K043509(SPECIAL)
ATTN: EARL E KNIGHT III PHONE NO : 812-339-2235
750 DANIELS WAY PO BX 489 SE DECISION MADE: 05-MAY-05
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR
COOPERVISION, INC. 510(k) NO: K050717(TRADITIONAL)
ATTN: BONNIE TSYMBAL PHONE NO : 585-264-3210
711 NORTH RD. SE DECISION MADE: 13-MAY-05
SCOTTSVILLE, NY 14546 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESSENPACS
CYMED ENGINEERING, INC. 510(k) NO: K051081(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 12-MAY-05
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CYNOSUREA ECLILITE AND ECLILITE U
CYNOSURE, INC. 510(k) NO: K050080(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 05-MAY-05
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000
CYTYC SURGICAL PRODUCTS 510(k) NO: K050650(TRADITIONAL)
ATTN: JIM TALBOT PHONE NO : 650-335-2600
1047 ELWELL CT. SE DECISION MADE: 16-MAY-05
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
DADE BEHRING, INC. 510(k) NO: K050665(TRADITIONAL)
ATTN: DONNA A WOLF PHONE NO : 302-631-0384
500 GBC DR., MAILSTOP 514 SE DECISION MADE: 02-MAY-05
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: SALUTE FIXATION SYSTEM
DAVOL INC., SUB. C.R. BARD, INC. 510(k) NO: K050610(TRADITIONAL)
ATTN: LUCINDA L FOX PHONE NO : 401-463-7000
100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 25-MAY-05
CRANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DDAT OMT
DDAT(UK) LTD 510(k) NO: K050098(TRADITIONAL)
ATTN: PETER LIOYD PHONE NO : 441 077 68815628
91 CLIDDESDEN ROAD SE DECISION MADE: 23-MAY-05
BASINGSTOKE, HAMPSHIRE, UNITED KIN510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POLYPROPILENE SURGICAL SUTURES
DEMETECH CORP. 510(k) NO: K043330(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 16-MAY-05
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELTON ILLUMINATING PIT AND FISSURE SEALING
DENTSPLY INTERNATIONAL 510(k) NO: K050959(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 W. PHILADELPHIA ST. SE DECISION MADE: 11-MAY-05
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: DELTA HUMERAL CUPS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K050315(SPECIAL)
ATTN: TIFFANI D ROGERS PHONE NO : 574-371-4927
700 ORTHOPAEDIC DR. SE DECISION MADE: 16-MAY-05
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: EPI-MAX
DERMAGENICS, INC. 510(k) NO: K041059(TRADITIONAL)
ATTN: STEVE MONROE PHONE NO : 901-452-2365
3251 POPLAR AVENUE SE DECISION MADE: 17-MAY-05
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
MEMPHIS, TN 38111
DEVICE: INTEGRA IMMOBILIZATION SYSTEM
DIACOR, INC. 510(k) NO: K050888(TRADITIONAL)
ATTN: GLENN N WATERMAN PHONE NO : 800-342-2679
3191 SOUTH 3300 EAST, SE DECISION MADE: 23-MAY-05
SUITE 100-A 510(k) SUMMARY AVAILABLE FROM FDA
SALT LAKE CITY, UT 84109
DEVICE: ECC.O SYSTEM
DIDECO S.R.L. 510(k) NO: K050890(SPECIAL)
ATTN: BARRY SALL PHONE NO : 781-434-4742
195 WEST ST. SE DECISION MADE: 05-MAY-05
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 4
DIDECO S.R.L. 510(k) NO: K051232(SPECIAL)
ATTN: BARRY SALL PHONE NO : 781-434-4742
195 WEST STREET SE DECISION MADE: 20-MAY-05
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUCHANGER
DIREX SYSTEMS CORP. 510(k) NO: K043409(TRADITIONAL)
ATTN: LARISA GERSTEIN PHONE NO : 508-651-0900
11 MERCER RD. SE DECISION MADE: 05-MAY-05
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DR. THEISS ALERGOL POLLEN BLOCKER CREAM
DR. THEISS NATURWAREN GMBH 510(k) NO: K042610(TRADITIONAL)
ATTN: STUART PORTNOY PHONE NO : 202-835-1355
815 CONNECTICUT AVE., NW SE DECISION MADE: 16-MAY-05
SUITE 800 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006
DEVICE: ELECTRODE
ELECTRAMOLD 510(k) NO: K050248(TRADITIONAL)
ATTN: E.W. JOHNSON PHONE NO : 502-429-4140
3600 CHAMBERLAIN LANE SE DECISION MADE: 25-MAY-05
SUITE 356 510(k) SUMMARY AVAILABLE FROM FDA
LOUISVILLE, KY 40241-1914
DEVICE: ENCORE REVERSE SHOULDER PROSTHESIS
ENCORE MEDICAL, L.P. 510(k) NO: K051075(SPECIAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 512-834-6298
9800 METRIC BLVD. SE DECISION MADE: 27-MAY-05
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENPATH DEFLECTABLE CATHETER
ENPATH MEDICAL INCORPORATED 510(k) NO: K043489(TRADITIONAL)
ATTN: KARYL D HASKELL PHONE NO : 952-653-2410
15301 HWY. 55 WEST SE DECISION MADE: 19-MAY-05
MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERCHONIA EVRL LASER
ERCHONIA MEDICAL, INC. 510(k) NO: K050672(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 02-MAY-05
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER
ETHICON ENDO-SURGERY, INC. 510(k) NO: K051002(TRADITIONAL)
ATTN: GEORGIA C ABERNATHY PHONE NO : 513-337-3179
4545 CREEK RD. SE DECISION MADE: 17-MAY-05
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVERLIFE
EVERLIFE MEDICAL INSTRUMENT CO., L510(k) NO: K050788(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 13-MAY-05
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
FIRST QUALITY HYGIENIC, INC. 510(k) NO: K050660(TRADITIONAL)
ATTN: ROBERT J STAAB PHONE NO : 201-327-0035
73 FRANKLIN TURNPIKE SE DECISION MADE: 12-MAY-05
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES
FIRSTLINE, LLC. 510(k) NO: K043149(TRADITIONAL)
ATTN: COLETTE PERCHES PHONE NO : 805-688-6768
760 MCMURRAY RD., SUITE B SE DECISION MADE: 25-MAY-05
BUELLTON, CA 93427 510(k) STATEMENT
DEVICE: CPAP HUMIDIFIER, MODEL HC238JHU
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K050904(TRADITIONAL)
ATTN: JAMES THOMPSON PHONE NO : 649 574 0100
15 MAURICE PAYKEL PLACE SE DECISION MADE: 25-MAY-05
EAST TAMAKI, NEW ZEALAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALUMINA HEAD
FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K050556(SPECIAL)
ATTN: CHRISTINE QUENDEZ PHONE NO : 332 985 56895
ZI DE KERNEVEZ-6 RUE NOBEL SE DECISION MADE: 11-MAY-05
QUIMPER, FRANCE 29000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P
FUJINON, INC. 510(k) NO: K050907(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203-944-9320
543 LONG HILL AVENUE SE DECISION MADE: 19-MAY-05
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-
GALIL MEDICAL LTD. 510(k) NO: K051052(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 06-MAY-05
WASHINGTON, DC 20009 510(k) STATEMENT
DEVICE: POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTI
GAMBRO RENAL PRODUCTS 510(k) NO: K043342(TRADITIONAL)
ATTN: KAE MILLER PHONE NO : 303-542-5045
10810 WEST COLLINS AVE. SE DECISION MADE: 27-MAY-05
LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
GE HEALTHCARE 510(k) NO: K050835(SPECIAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 06-MAY-05
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E
GE HEALTHCARE 510(k) NO: K051092(SPECIAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 25-MAY-05
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K050093(TRADITIONAL)
ATTN: RONALD N BLASKI PHONE NO : 414-362-2348
8200 WEST TOWER AVE. SE DECISION MADE: 13-MAY-05
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K050731(TRADITIONAL)
ATTN: LISA M BAUMHARDT PHONE NO : 262-293-1699
8200 WEST TOWER AVE. SE DECISION MADE: 19-MAY-05
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE VIEWPOINT
GENERAL ELECTRIC CO. 510(k) NO: K050943(TRADITIONAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
P.O. BOX 414 SE DECISION MADE: 23-MAY-05
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPAND CORPECTOMY SPACER
GLOBUS MEDICAL INC. 510(k) NO: K050850(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000
303 SCHELL LN. SE DECISION MADE: 26-MAY-05
PHOENIXVILLE, PA 19460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE
H.B.M. USA CO.,INC. 510(k) NO: K050071(TRADITIONAL)
ATTN: GORDON X HU PHONE NO : 718-776-6666
HBM BUILDING, 98-02, 218 ST., SE DECISION MADE: 11-MAY-05
QUEEN'S VILLAGE, NY 11429 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESO-PAC PERIODONTAL DRESSING
HAGER WORLDWIDE, INC. 510(k) NO: K050658(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-261-1000
2000 M STREET, N.W. 7TH FLOOR SE DECISION MADE: 27-MAY-05
WASHINGTON, DC 20036-3307 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALDAHOL III HIGH-LEVEL DISINFECTANT
HEALTHPOINT, LTD. 510(k) NO: K041360(TRADITIONAL)
ATTN: NORM MINER, PHD PHONE NO : 817-283-9100
1107-C S. AIRPORT CIRCLE SE DECISION MADE: 05-MAY-05
EULESS (DALLAS), TX 76040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED
HEBEI MANFUL IMPORT & EXPORT CO., 510(k) NO: K051153(TRADITIONAL)
ATTN: YANCHAI ZHANG PHONE NO : 86 331 4338239
NO. 58 TONGDA ROAD SE DECISION MADE: 18-MAY-05
JINZHOU CITY, HEBEI, CHINA 052260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
HOLOGIC, INC. 510(k) NO: K051025(SPECIAL)
ATTN: DANIEL F PHELAN PHONE NO : 781-999-7358
35 CROSBY DR. SE DECISION MADE: 13-MAY-05
BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING
HOSPICARE, INC. 510(k) NO: K051079(SPECIAL)
ATTN: YULIYA MATLIN PHONE NO : 224-212-4857
275 NORTH FIELD DRIVE SE DECISION MADE: 19-MAY-05
DEPT. 389, BLDG. H2 510(k) SUMMARY AVAILABLE FROM FDA
LAKE FOREST, IL 60045
DEVICE: TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060
IDEV TECHNOLOGIES, INC. 510(k) NO: K050926(SPECIAL)
ATTN: SHANNON HURD PHONE NO : 281-333-1998
1110 NASA RD. ONE SE DECISION MADE: 09-MAY-05
SUITE 311 510(k) SUMMARY AVAILABLE FROM FDA
HOUSTON, TX 77058-3345
DEVICE: PROCON2
INCONTINENT CONTROL DEVICES, INC. 510(k) NO: K042431(TRADITIONAL)
ATTN: NYLE ELLIOTT PHONE NO : 281-360-4638
2727 BENS BRANCH DRIVE SE DECISION MADE: 27-MAY-05
SUITE 1302 510(k) SUMMARY AVAILABLE FROM FDA
KINGWOOD, TX 77339
DEVICE: IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
IND DIAGNOSTIC INC. 510(k) NO: K050741(TRADITIONAL)
ATTN: JASON PENG PHONE NO : 604 522 1619
1629 FOSTERS WAY SE DECISION MADE: 16-MAY-05
DELTA, B.C., CANADA V3M 6S7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE
INION LTD. 510(k) NO: K051341(SPECIAL)
ATTN: HANNA MARTTILA PHONE NO : 358 3 2306600
LAAKARINKATU 2 SE DECISION MADE: 27-MAY-05
TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IT NASAL MASK
INNOMED TECHNOLOGIES 510(k) NO: K050171(TRADITIONAL)
ATTN: FRANK PELC PHONE NO : 724-838-7880
6601 LYONS ROAD SE DECISION MADE: 04-MAY-05
SUITES B1-B-4 510(k) SUMMARY AVAILABLE FROM FDA
COCONUT CREEK, FL 33073
DEVICE: EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 902
INNTEC, INC. 510(k) NO: K050521(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 02-MAY-05
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA PLEX ANCA PROFILE
INOVA DIAGNOSTICS, INC. 510(k) NO: K050715(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 858-586-9900
9900 OLD GROVE RD. SE DECISION MADE: 12-MAY-05
SAN DIEGO, CA 92131-1638 510(k) STATEMENT
DEVICE: INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICA
INOVEL LLC 510(k) NO: K051182(ABBREVIATED)
ATTN: WILLIAM WAWRZYNIAK PHONE NO : 866-546-6835
10111 W. JEFFERSON BLVD. SE DECISION MADE: 19-MAY-05
CULVER CITY, CA 90232-3509 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HEMOSIL FACTOR II DEFICIENT PLASMA
INSTRUMENTATION LABORATORY CO. 510(k) NO: K050661(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 02-MAY-05
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITO
INTEGRA NEUROSCIENCES 510(k) NO: K050720(SPECIAL)
ATTN: NANCY A MATHEWSON PHONE NO : 609-936-2311
311 ENTERPRISE DR. SE DECISION MADE: 11-MAY-05
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRMA TRUPOINT CREATININE CONTROL KIT
INTERNATIONAL TECHNIDYNE CORPORATI510(k) NO: K050983(TRADITIONAL)
ATTN: NANCY RING PHONE NO : 651-638-1250
2656 PATTON RD. SE DECISION MADE: 16-MAY-05
ROSEVILLE, MN 55113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEEK CAS
INTERPORE CROSS INTL. 510(k) NO: K050861(SPECIAL)
ATTN: WENDY SPIELBERGER PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 27-MAY-05
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKIPPER AND SKIPPER RACE GUIDEWIRE
INVATEC INNOVATIVE TECHNOLOGIES, S510(k) NO: K050756(TRADITIONAL)
ATTN: MELISSA SOMMERFELD PHONE NO : 763-398-7612
4600 NATHAN LANE NORTH SE DECISION MADE: 05-MAY-05
PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050
IVOCLAR VIVADENT, INC. 510(k) NO: K050453(TRADITIONAL)
ATTN: DONNA HARNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 27-MAY-05
AMHERST, NY 14228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JEIL BONE FIXATION SYSTEM
JEIL MEDICAL CORPORATION 510(k) NO: K050669(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 26-MAY-05
DEERFILED, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE LF-P CERAMIC SYSTEM
JENSEN INDUSTRIES, INC. 510(k) NO: K050838(ABBREVIATED)
ATTN: GARY PHELPS PHONE NO : 203-239-2090
50 STILLMAN RD. SE DECISION MADE: 04-MAY-05
NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM
KERBEROS PROXIMAL SOLUTIONS, INC. 510(k) NO: K050130(TRADITIONAL)
ATTN: TOM MASON PHONE NO : 408-253-3319
10600 NORTH TANTAU AVE. SE DECISION MADE: 13-MAY-05
CUPERTINO, CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIPRO SHOULDER SOFTWARE MODULE
KINAMED, INC. 510(k) NO: K050897(TRADITIONAL)
ATTN: VINEET K SARIN PHONE NO : 805-384-2748
820 FLYNN RD. SE DECISION MADE: 24-MAY-05
CAMARILLO, CA 93012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
KINETIC CONCEPTS, INC. 510(k) NO: K050261(TRADITIONAL)
ATTN: CHRISTY OVIATT PHONE NO : 210-255-6105
8023 VANTAGE DR. SE DECISION MADE: 26-MAY-05
SAN ANTONIO, TX 78230-4726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARMAND ENDOSCOPE HOLDER
KLS-MARTIN L.P. 510(k) NO: K050051(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746
11239-1 ST. JOHN'S IND. PKWY. SE DECISION MADE: 16-MAY-05
SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: LANX SPINAL FIXATION SYSTEM
LANX, LLC 510(k) NO: K043484(ABBREVIATED)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 16-MAY-05
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389
DEVICE: PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T
LEMAITRE VASCULAR, INC. 510(k) NO: K051067(SPECIAL)
ATTN: AMY WATZKE PHONE NO : 781-221-2266
63 2ND AVENUE SE DECISION MADE: 27-MAY-05
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX IN
LENSTEC, INC. 510(k) NO: K050638(TRADITIONAL)
ATTN: LUIS RUIZ PHONE NO : 727-571-2272
2870 SCHERER DR., SUITE 300 SE DECISION MADE: 31-MAY-05
ST. PETERSBURG, FL 33716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROBLOC, HN SERIES AND PROLONG, PL SERIES
LIFE-TECH, INC. 510(k) NO: K050499(TRADITIONAL)
ATTN: JEFF KASOFF PHONE NO : 281-491-6600
4235 GREENBRIAR DR. SE DECISION MADE: 17-MAY-05
STAFFORD, TX 77477-3995 510(k) STATEMENT
DEVICE: ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SY
LIFESCAN, INC. 510(k) NO: K043197(TRADITIONAL)
ATTN: MARY ELLEN HOLDEN PHONE NO : 408-942-3589
1000 GIBRALTAR DR. SE DECISION MADE: 20-MAY-05
MILPITAS, CA 95035-6312 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE
LIGHTSPEED TECHNOLOGY, INC. 510(k) NO: K050612(TRADITIONAL)
ATTN: STEVEN SENIA PHONE NO : 210-495-4942
403 E RAMSEY SUITE 205 SE DECISION MADE: 04-MAY-05
SAN ANTONIO, TX 78216 510(k) STATEMENT
DEVICE: ADVANCED TURBO DRIVE SYSTEM
LINVATEC CORP. 510(k) NO: K050519(SPECIAL)
ATTN: ELIZABETH PAUL PHONE NO : 727-399-5234
11311 CONCEPT BLVD. SE DECISION MADE: 17-MAY-05
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MC6A
MACAN ENGINEERING CO. 510(k) NO: K050735(TRADITIONAL)
ATTN: RICH GARRETT PHONE NO : 773-772-2000
1564 NORTH DAMEN SE DECISION MADE: 23-MAY-05
CHICAGO, IL 60622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: VOYAGER LINUX
MAKO SURGICAL CORP. 510(k) NO: K050973(SPECIAL)
ATTN: WILLIAM F TAPIA PHONE NO : 954-927-2044
2901 SIMMS STREET SE DECISION MADE: 17-MAY-05
HOLLYWOOD, FL 33020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MARINA MEDICAL FINGER PROTECTORS
MARINA MEDICAL INSTRUMENTS, INC. 510(k) NO: K042534(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 770-777-4146
1308 MORNINGSIDE PARK DR. SE DECISION MADE: 10-MAY-05
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS
MASIMO CORPORATION 510(k) NO: K050252(SPECIAL)
ATTN: JAMES J CRONIN PHONE NO : 949-297-7218
40 PARKER SE DECISION MADE: 11-MAY-05
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGI-WRAP MAST BIORESORBABLE SHEET
MAST BIOSURGERY USA INC. 510(k) NO: K050332(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900
6749 TOP GUN ST., SUITE C SE DECISION MADE: 27-MAY-05
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN
MDS NORDION 510(k) NO: K050963(SPECIAL)
ATTN: ROSS KACHANIWSKY PHONE NO : 613 592 3400
447 MARCH RD. SE DECISION MADE: 20-MAY-05
OTTAWA, ONTARIO, CANADA K2K1X8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAYCELL X-RAY BLOOD IRRADIATOR
MDS NORDION 510(k) NO: K051065(SPECIAL)
ATTN: ROSS KACHANIWSKY PHONE NO : 613 592 2790
447 MARCH RD. SE DECISION MADE: 26-MAY-05
OTTAWA, ONTARIO, CANADA K2K1X8 510(k) STATEMENT
DEVICE: MODUS TITANIUM OSTEOSYNTHESIS SYSTEM
MEDARTIS, INC. 510(k) NO: K050934(SPECIAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON ROAD SE DECISION MADE: 05-MAY-05
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WINDSURFER
MEDCON LTD. 510(k) NO: K050561(TRADITIONAL)
ATTN: ELI M ORBACH PHONE NO : 972 299 32768
POB 6718 SE DECISION MADE: 04-MAY-05
EFRAT, ISRAEL 90435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANALIZER HYDROPHILIC GUIDE WIRE
MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K050873(TRADITIONAL)
ATTN: KRISTINE LIBERACKI PHONE NO : 800-338-0440
3600 SW 47TH AVENUE SE DECISION MADE: 26-MAY-05
GAINESVILLE, FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMREST HEATED HUMIDIFIER
MEDICAL INDUSTRIES AMERICA, INC. 510(k) NO: K050990(TRADITIONAL)
ATTN: KEITH THEISEN PHONE NO : 515-993-5001
2636 289TH PLACE SE DECISION MADE: 02-MAY-05
ADEL, IA 50003-8021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MMS VIDEO OPTION
MEDICAL MEASUREMENT SYSTEMS,B.V. 510(k) NO: K050993(TRADITIONAL)
ATTN: KARIN OGINK-SOMHORST PHONE NO : 31 53 4803739
COLOSSEUM 25 SE DECISION MADE: 26-MAY-05
ENSCHEDE, NETHERLANDS 7521 PV 510(k) STATEMENT
DEVICE: HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K051040(SPECIAL)
ATTN: BRUSS BACKLUND PHONE NO : 763-391-9183
7611 NORTHLAND DR. SE DECISION MADE: 24-MAY-05
MINNEAPOLIS, MN 55038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K050981(SPECIAL)
ATTN: RICHARD TRECHAME PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 17-MAY-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BASIS SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K051039(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 12-MAY-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BASIS SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K050484(TRADITIONAL)
ATTN: RICHARD TREHARME PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 04-MAY-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDX HOME
MEDX ELECTRONICS, INC. 510(k) NO: K050022(TRADITIONAL)
ATTN: ANITA SALTMARCHE PHONE NO : 888-363-3112
3350 RIDGEWAY DRIVE UNIT 3 SE DECISION MADE: 05-MAY-05
MISSISSAUGA ON, CANADA L5L 5Z9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERETE DUOTHREADTM BONE SCREW
MERETE MEDICAL GMBH 510(k) NO: K050924(TRADITIONAL)
ATTN: JENIK RADON PHONE NO : 212-496-2700
269 WEST SEVENTY-FIRST STREET SE DECISION MADE: 27-MAY-05
NEW YORK, NY 10023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERIT PRELUDE SHEATH INTRODUCER
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K050962(TRADITIONAL)
ATTN: JERRIE HENDRICKSON PHONE NO : 801-253-1600
1600 WEST MERIT PKWY. SE DECISION MADE: 06-MAY-05
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PIONEER U121 SERIES CPAP
MERITS HEALTH PRODUCTS CO., LTD. 510(k) NO: K041823(TRADITIONAL)
ATTN: STEVE CHAO PHONE NO : 886 4 23594985
9, ROAD 36 SE DECISION MADE: 10-MAY-05
TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN) 407
DEVICE: 90XL INSTRUMENTATION SYSTEM
MESA LABORATORIES, INC. 510(k) NO: K050812(SPECIAL)
ATTN: TODD ROMERO PHONE NO : 303-987-8000
12100 WEST 6TH AVE. SE DECISION MADE: 05-MAY-05
LAKEWOOD, CO 80228 510(k) STATEMENT
DEVICE: LASER SYS*STIM 540, MODEL ME 540
METTLER ELECTRONICS CORP. 510(k) NO: K043586(ABBREVIATED)
ATTN: ROBERT E FLEMING PHONE NO : 714-533-2221
1333 SOUTH CLAUDINA ST. SE DECISION MADE: 06-MAY-05
ANAHEIM, CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-CHANGE
MEYRA 510(k) NO: K051090(TRADITIONAL)
ATTN: KIRK MACKENZIE PHONE NO : 704-882-0668
12801 EAST INDEPENDENCE BLVD. SE DECISION MADE: 13-MAY-05
MATTHEWS, NC 28106 510(k) STATEMENT
DEVICE: BRIX WHEELCHAIR
MEYRA, INC. 510(k) NO: K050941(TRADITIONAL)
ATTN: KIRK MACKENZIE PHONE NO : 704-882-0668
12801 EAST INDEPENDENCE BLVD. SE DECISION MADE: 05-MAY-05
MATTHEWS, NC 28106 510(k) STATEMENT
DEVICE: MICROPUMP MP-101
MICREL MEDICAL DEVICES S.A. 510(k) NO: K051252(TRADITIONAL)
ATTN: ALEXANDRE TSOUKALIS PHONE NO : 302 106 032334
ITHAKIS 4 SE DECISION MADE: 27-MAY-05
PALLINI, GREECE 15351 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K051100(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 417 172 77000
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 11-MAY-05
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROTEK EQUIPMENT DRAPES
MICROTEK MEDICAL, INC. 510(k) NO: K050322(TRADITIONAL)
ATTN: THOMAS BONNER PHONE NO : 662-327-1863
512 LEHMBERG RD. SE DECISION MADE: 17-MAY-05
COLUMBUS, MS 39702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FT2000 SEQUENCER FOR MUSCLE STIMULATOR
MIDWEST DEVELOPMENT 510(k) NO: K050595(TRADITIONAL)
ATTN: STEPHEN GORSKI PHONE NO : 262-594-2114
S65 W35739 PIPER ROAD SE DECISION MADE: 23-MAY-05
EAGLE, WI 53119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STICK ELECTRODE
MODERN MEDICAL EQUIPMENT MFG., LTD510(k) NO: K043036(TRADITIONAL)
ATTN: ROBERT STILLMAN PHONE NO : 804-353-7160
1705 DABNEY ROAD SE DECISION MADE: 06-MAY-05
RICHMOND, VA 23230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARRIER SURGICAL GOWNS
MOLNLYCKE HEALTH CARE 510(k) NO: K050786(SPECIAL)
ATTN: JOHN CLAY PHONE NO : 267-685-2078
826 NEWTON YARDLEY RD. SE DECISION MADE: 09-MAY-05
NEWTON, PA 18940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUELEX
MONITEX INDUSTRIAL CO., LTD. 510(k) NO: K051203(TRADITIONAL)
ATTN: SHU-LUNG WANG PHONE NO : 886 228 938098
6F, 70 GUANG-FU RD., SEC 1, SE DECISION MADE: 25-MAY-05
SAN-CHUNG CITY 510(k) STATEMENT
TAIPEI, CHINA (TAIWAN) 241-58 THIRD PARTY REVIEW
DEVICE: SPIRO'AIR
MORGAN SCIENTIFIC, INC. 510(k) NO: K042595(TRADITIONAL)
ATTN: PATRICK MORGAN PHONE NO : 978-521-4440
151 ESSEX ST. SE DECISION MADE: 04-MAY-05
HAVERHILL, MA 01832 510(k) STATEMENT
DEVICE: EZ-STIK ELECTRODES
NAIMCO, INC. 510(k) NO: K050469(TRADITIONAL)
ATTN: ROBERT L MCCLURE PHONE NO : 888-549-4945
4120 SOUTH CREEK ROAD SE DECISION MADE: 13-MAY-05
CHATTANOOGA, TN 37406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPI
NANO-DITECH CO. 510(k) NO: K050594(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD. SE DECISION MADE: 15-MAY-05
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: INTERX5000
NEURO RESOURCE GROUP, INC. 510(k) NO: K042912(TRADITIONAL)
ATTN: KRISTA OAKES PHONE NO : 972-438-5202
2220 CHEMSEARCH BLVD. SE DECISION MADE: 17-MAY-05
SUITE 108 510(k) SUMMARY AVAILABLE FROM FDA
IRVING, TX 75062
DEVICE: NEUROSYSTEMS 1TM MONITOR
NEUROSYSTEMS LLC 510(k) NO: K050702(TRADITIONAL)
ATTN: JAMES R PETITE JR. PHONE NO : 802-457-9866
103 POMFRET ROAD SE DECISION MADE: 17-MAY-05
WOODSTOCK, VT 05091-8029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEWDEAL ANKLE NAIL
NEWDEAL S.A. 510(k) NO: K050882(TRADITIONAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311
311 ENTERPRISE DRIVE SE DECISION MADE: 27-MAY-05
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMIGO INSULIN PUMP
NIPRO DIABETES SYSTEMS, INC. 510(k) NO: K050312(TRADITIONAL)
ATTN: CLARENCE ODOM PHONE NO : 954-435-5665
3361 ENTERPRISE WAY SE DECISION MADE: 09-MAY-05
MIRAMAR, FL 33025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMONIR TM
NIR DIAGNOSTICS, INC. 510(k) NO: K050014(TRADITIONAL)
ATTN: CYNTHIA A SINCLAIR PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 05-MAY-05
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPRESSION ANASTOMOSIS RING (CAR)
NITI MEDICAL TECHNOLOGIES LTD. 510(k) NO: K050356(TRADITIONAL)
ATTN: ORLY MAOR PHONE NO : 972 986 50610
1 HATZORAN ST. SE DECISION MADE: 05-MAY-05
P.O. BOX 8634 510(k) SUMMARY AVAILABLE FROM FDA
NETANYA, ISRAEL 42506
DEVICE: THE GUIDED SURGERY CONCEPT
NOBEL BIOCARE AB 510(k) NO: K050393(TRADITIONAL)
ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800
22715 SAVI RANCH PKWY. SE DECISION MADE: 04-MAY-05
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIUNITE IMPLANTS
NOBEL BIOCARE AB 510(k) NO: K050705(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714-282-5074
22715 SAVI RANCH PKWY. SE DECISION MADE: 19-MAY-05
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CZR PRESS LF STAINS
NORITAKE CO., INC. 510(k) NO: K050920(TRADITIONAL)
ATTN: IVAN J WASSERMAN PHONE NO : 202-342-8400
3050 K STREET, NW, STE 400 SE DECISION MADE: 11-MAY-05
WASHINGTON, DC 20007 510(k) STATEMENT
DEVICE: NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION
NTI-TSS, INC. 510(k) NO: K041184(TRADITIONAL)
ATTN: JAMES BOYD PHONE NO : 858-759-7149
5327 LA GLORIETA PO BX 2145 SE DECISION MADE: 03-MAY-05
RANCHO SANTA FE, CA 92067-2145 510(k) STATEMENT
DEVICE: MICROCYN WOUND CARE DRESSING
OCULUS INNOVATIVE SCIENCES, INC. 510(k) NO: K041161(TRADITIONAL)
ATTN: MANISHA S DESHMUKH PHONE NO : 707-782-0792
1129 N. MCDOWELL BLVD. SE DECISION MADE: 03-MAY-05
PETALUMA, CA 94954 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMACYN WOUND IRRIGATION
OCULUS INNOVATIVE SCIENCES, INC. 510(k) NO: K042729(TRADITIONAL)
ATTN: MOANISHA DESHMUKH PHONE NO : 707-782-0792
1129 N. MCDOWELL BLVD. SE DECISION MADE: 17-MAY-05
PETALUMA, CA 94954 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LASIK EYE DRAPE
ODYSSEY MEDICAL, INC. 510(k) NO: K042977(TRADITIONAL)
ATTN: IVAN HARLAN PHONE NO : 901-383-7777
5828 SHELBY OAKS DR. SE DECISION MADE: 10-MAY-05
MEMPHIS, TN 38134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K050503(TRADITIONAL)
ATTN: LARUA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DR. SE DECISION MADE: 12-MAY-05
MELVILLE, NY 11747-9058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY
OMNIGUIDE COMMUNICATIONS, INC. 510(k) NO: K050541(TRADITIONAL)
ATTN: IRINA KULINETS PHONE NO : 617-551-8404
ONE KENDALL SQUARE, BLDG 100 SE DECISION MADE: 09-MAY-05
3RD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
CAMBRIDGE, MA 02139
DEVICE: OMNITECH FULGURATING ELECTRODE
OMNITECH SYSTEMS, INC. 510(k) NO: K050454(TRADITIONAL)
ATTN: JON D BARRETT PHONE NO : 219-531-5532
456 SOUTH CAMBELL, BLDG. C SE DECISION MADE: 27-MAY-05
VALPARAISO, IN 46385 510(k) STATEMENT
DEVICE: LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM
OPHTHOCARE LTD. 510(k) NO: K050856(TRADITIONAL)
ATTN: DORIT WINITZ PHONE NO : 972 361 23281
11 MENACHEM BEGIN ST. SE DECISION MADE: 31-MAY-05
RAMAT-GAN, ISRAEL 52521 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORION DIAGNOSTICA UNIQ PINP RIA
ORION DIAGNOSTICA OY 510(k) NO: K043125(TRADITIONAL)
ATTN: ANNIKKA RANTAMA PHONE NO : 358 104 292736
KOIVU MANKKAAN TIE 6 SE DECISION MADE: 04-MAY-05
ESPOO, FINLAND 02200 510(k) STATEMENT
DEVICE: MAXLOCK
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K050868(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-546-9810
5905 FAWN LANE SE DECISION MADE: 27-MAY-05
CLEVELAND, OH 44141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANIUM-HIP TOOL
ORTHOPEDIC SCIENCES, INC 510(k) NO: K051032(SPECIAL)
ATTN: JAMES K BRANNON PHONE NO : 310-242-6643
6080 CENTER DR., 6TH FLOOR SE DECISION MADE: 23-MAY-05
HOWARD HUGHES CENTER 510(k) SUMMARY AVAILABLE FROM FDA
LOS ANGELES, CA 90045
DEVICE: CUSTOM-HIP TOOL
ORTHOPEDIC SCIENCES, INC 510(k) NO: K051181(SPECIAL)
ATTN: JAMES K BRANNON PHONE NO : 310-242-6643
6080 CENTER DR., 6TH FLOOR SE DECISION MADE: 23-MAY-05
HOWARD HUGHES CENTER 510(k) SUMMARY AVAILABLE FROM FDA
LOS ANGELES, CA 90045
DEVICE: BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7
OSTAR MEDITCH CORP. 510(k) NO: K050680(TRADITIONAL)
ATTN: STEVEN CHANG PHONE NO : 886 229 182390
5F, NO. 46-4, MIN-CHIUAN RD. SE DECISION MADE: 13-MAY-05
SHING-TIEN CITY 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI HSIEN, CHINA (TAIWAN) 231
DEVICE: THE HERMES SYSTEM
PALAISTRA SYSTEMS INC. 510(k) NO: K050929(TRADITIONAL)
ATTN: PATRIC GORA PHONE NO : 507-269-2895
408 19TH STREET SW SE DECISION MADE: 20-MAY-05
ROCHESTER, MN 55902 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ULTRASONIC BIO-MICROSCOPE, MODEL P60
PARADIGM MEDICAL INDUSTRIES, INC. 510(k) NO: K050980(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-546-9810
5905 FAWN LANE SE DECISION MADE: 26-MAY-05
CLEVELAND, OH 44141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEMINI GXL
PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K051170(TRADITIONAL)
ATTN: RAE ANN FARROW PHONE NO : 440-483-2647
595 MINER RD. SE DECISION MADE: 23-MAY-05
CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NEUROLAC NERVE GUIDE
POLYGANICS BV 510(k) NO: K050573(TRADITIONAL)
ATTN: JAN NIEUWENHUIS PHONE NO : 315 058 86588
L.J. ZIELSTRAWEG 1 SE DECISION MADE: 04-MAY-05
GRONINGEN, NETHERLANDS 9713-GX 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECIMED CANNULATED SCREW SYSTEM
PRECIMED, INC. 510(k) NO: K050754(TRADITIONAL)
ATTN: BARBARA LYONS PHONE NO : 610-524-8300
102 PICKERING WAY SE DECISION MADE: 18-MAY-05
SUITE 508 510(k) SUMMARY AVAILABLE FROM FDA
EXTON, PA 19341
DEVICE: WIMRT MODULE FOR ARTP PLANNING SYSTEM
PRODIGM GROUP, INC. 510(k) NO: K041971(TRADITIONAL)
ATTN: LEE POTTS PHONE NO : 530-432-5846
19078 CHAPARRAL DRIVE SE DECISION MADE: 20-MAY-05
PENN VALLEY, CA 95946 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOMPO TEST
PROGNOSTIX, INC. 510(k) NO: K050029(TRADITIONAL)
ATTN: THOMAS M JACKSON PHONE NO : 216-445-7469
10265 CARNEGIE AVENUE SE DECISION MADE: 10-MAY-05
CLEVELAND, OH 44106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOTIFMESH SOFT TISSUE PATCH
PROXY BIOMEDICAL LTD. 510(k) NO: K050678(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 20-MAY-05
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOSCOPE SONOPLUS 3000
PULSONIC AG, MEDICAL TECHNOLOGY 510(k) NO: K051126(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 770-777-4146
1308 MORNINGSIDE PARK DRIVE SE DECISION MADE: 19-MAY-05
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FORMAGRAFT COLLAGEN BONE GRAFT MATRIX
R AND D MEDICAL, LLC 510(k) NO: K050789(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON ROAD SE DECISION MADE: 27-MAY-05
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX
RADIOMETER MEDICAL APS 510(k) NO: K043218(TRADITIONAL)
ATTN: LENE MEINECHE MARNAES PHONE NO : 45 382 73827
AKANDEVEJ 21 SE DECISION MADE: 10-MAY-05
BRONSHOJ, DENMARK DK-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX BENZODIAZEPINE CLASS ASSAY
RANDOX LABORATORIES, LTD. 510(k) NO: K050179(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 440 28 94422413
55 DIAMOND RD. SE DECISION MADE: 17-MAY-05
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: ADAPTER CABLE
REMINGTON MEDICAL, INC. 510(k) NO: K050884(TRADITIONAL)
ATTN: DON ROSVOLD PHONE NO : 770-888-8520
6830 MEADOWRIDGE CT. SE DECISION MADE: 19-MAY-05
ALPHARETTA, GA 30005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESSCAN
RESMED LTD. 510(k) NO: K050775(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 10-MAY-05
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCU-CHEK INTEGRA SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K050872(SPECIAL)
ATTN: SCOTT THIEL PHONE NO : 317-521-3362
9115 HAGUE RD. SE DECISION MADE: 02-MAY-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011
SCANTIBODIES LABORATORY, INC. 510(k) NO: K050748(TRADITIONAL)
ATTN: MICHAEL NORDSTROM PHONE NO : 619-258-9300
9336 ABRAHAM WAY SE DECISION MADE: 20-MAY-05
SANTEE, CA 92071 510(k) STATEMENT
DEVICE: CARDIOVIT AT-10PLUS
SCHILLER AG 510(k) NO: K050686(TRADITIONAL)
ATTN: MARKUS BUETLER PHONE NO : 414 176 64252
ALTGASSE 68 SE DECISION MADE: 04-MAY-05
BAAR, SWITZERLAND CH-6341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CO VERTEBRAL BODY REPLACEMENT
SCIENT'X 510(k) NO: K050348(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 27-MAY-05
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYAXIAL HEMISPHERICAL SPINAL SCREWS
SCIENT'X 510(k) NO: K051063(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 23-MAY-05
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMORGON ULTRASOUND PACS SOLUTIONS
SEA RIDGE SOFTWARE, INC. 510(k) NO: K050736(TRADITIONAL)
ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648
16303 PANORAMIC WAY SE DECISION MADE: 05-MAY-05
SAN LEANDRO, CA 94578-1116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENCOR 7 GAUGE
SENORX, INC. 510(k) NO: K051158(SPECIAL)
ATTN: AMY BOUCLY PHONE NO : 949-362-4800
11 COLUMBIA, SUITE A SE DECISION MADE: 16-MAY-05
ALISO VIEJO, CA 92656 510(k) STATEMENT
DEVICE: SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70
SEPTODONT 510(k) NO: K051010(SPECIAL)
ATTN: WAYNE H MATELSKI PHONE NO : 202-857-6340
1050 CONNECTICUT AVE., NW SE DECISION MADE: 02-MAY-05
WASHINGTON, DC 20036 510(k) STATEMENT
DEVICE: ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K051139(TRADITIONAL)
ATTN: ISKRA MRAKOVIC PHONE NO : 650-694-5004
1230 SHOREBIRD WAY SE DECISION MADE: 13-MAY-05
P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94039-7393 THIRD PARTY REVIEW
DEVICE: HA COATED LAG SCREW
SMITH & NEPHEW, INC. 510(k) NO: K050849(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 E. BROOKS RD. SE DECISION MADE: 04-MAY-05
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX
SMITH & NEPHEW, INC. 510(k) NO: K050898(TRADITIONAL)
ATTN: KAREN PROVENCHER PHONE NO : 978-749-1365
150 MINUTEMAN RD. SE DECISION MADE: 25-MAY-05
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KNEE FUSION NAIL
SMITH & NEPHEW, INC. 510(k) NO: K050938(TRADITIONAL)
ATTN: LAURIE JORDAN PHONE NO : 901-399-5042
1450 E. BROOKS RD. SE DECISION MADE: 04-MAY-05
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW PATELLO-FEMORAL IMPLANT
SMITH & NEPHEW, INC. 510(k) NO: K051086(ABBREVIATED)
ATTN: GINO ROUSS PHONE NO : 901-399-6707
1450 E. BROOKS RD. SE DECISION MADE: 31-MAY-05
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT
SMITHS MEDICAL 510(k) NO: K050166(TRADITIONAL)
ATTN: CHRISTOPHER TURNBULL PHONE NO : 004 401 303236771
MILITARY ROAD SE DECISION MADE: 26-MAY-05
HYTHE, KENT, UNITED KINGDOM CT 21 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
SOLCO BIOMEDICAL CO., LTD. 510(k) NO: K050471(TRADITIONAL)
ATTN: SAEYOUNG AHN PHONE NO : 301-469-7912
7612 BARNUM ROAD SE DECISION MADE: 12-MAY-05
BETHESDA, MD 20817 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
SPACELABS MEDICAL INC. 510(k) NO: K050605(SPECIAL)
ATTN: AL VAN HOUDT PHONE NO : 425-657-7200
5150 220TH AVE SE SE DECISION MADE: 03-MAY-05
PO BOX 7018 510(k) SUMMARY AVAILABLE FROM FDA
ISSAQUAH, WA, WA 98027-7018
DEVICE: EUTROCHAR
SPECIAL DEVICES, INC. 510(k) NO: K050957(TRADITIONAL)
ATTN: JOSEPH J SPRANZA III PHONE NO : 530-273-6763
12493 OLD ROUGH AND READY HWY. SE DECISION MADE: 18-MAY-05
GRASS VALLEY, CA 95945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINILOC SAFETY INFUSION SET
SPECIALIZED HEALTH PRODUCTS, INTL.510(k) NO: K050600(TRADITIONAL)
ATTN: MARK NELSON PHONE NO : 801-298-3360
585 WEST 500 SOUTH SE DECISION MADE: 12-MAY-05
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
BOUNTIFUL, UT 84010
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,G
SPI GLOVES SDN. BHD. 510(k) NO: K050528(TRADITIONAL)
ATTN: CHOOI FONG CHUN PHONE NO : 605 322 3200
5, PERSIARAN GREENTOWN 8 SE DECISION MADE: 19-MAY-05
GREENTOWN BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA
IPOH 30450, MALAYSIA
DEVICE: FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE
SPINAL CONCEPTS, INC. 510(k) NO: K051000(SPECIAL)
ATTN: NOAH BARTSCH PHONE NO : 512-533-1840
5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 19-MAY-05
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK
SPS MEDICAL SUPPLY CORP. 510(k) NO: K051173(SPECIAL)
ATTN: GARY J SOCOLA PHONE NO : 585-359-0130
6789 WEST HENRIETTA RD. SE DECISION MADE: 27-MAY-05
RUSH, NY 14543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 4
ST. JUDE MEDICAL, DAIG DIVISION, I510(k) NO: K051096(SPECIAL)
ATTN: MIKE BURNSIDE PHONE NO : 952-351-1453
14901 DEVEAU PL. SE DECISION MADE: 17-MAY-05
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS
STANDARD TEXTILE CO., INC. 510(k) NO: K041540(TRADITIONAL)
ATTN: BRADLEY J BUSHMAN PHONE NO : 513-761-9255
ONE KNOLLCREST DR. SE DECISION MADE: 05-MAY-05
P.O. BOX 371805 510(k) SUMMARY AVAILABLE FROM FDA
CINCINNATI, OH 45237-1600
DEVICE: REPROCESSED ENDOSCOPIC TROCAR
STERILMED, INC. 510(k) NO: K043592(TRADITIONAL)
ATTN: BRUCE R LESTER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH, #100 SE DECISION MADE: 23-MAY-05
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
STRYKER INSTRUMENTS 510(k) NO: K043442(TRADITIONAL)
ATTN: JEAN SHEPPARD PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 31-MAY-05
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PAINPUMP2
STRYKER INSTRUMENTS 510(k) NO: K043466(TRADITIONAL)
ATTN: JENNIFER MARS PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 10-MAY-05
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER DISCMONITOR
STRYKER INSTRUMENTS 510(k) NO: K050753(TRADITIONAL)
ATTN: JEAN W SHEPPARD PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 18-MAY-05
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DDRCOMBI TRAUMA
SWISSRAY INTL., INC. 510(k) NO: K050718(TRADITIONAL)
ATTN: JOHN MONAHAN PHONE NO : 908-353-0971
1180 MCLESTER STREET SE DECISION MADE: 26-MAY-05
ELIZABETH, NJ 07201 510(k) STATEMENT
DEVICE: MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE
SYNTHES (USA) 510(k) NO: K042606(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 610-719-5860
1690 RUSSELL RD. SE DECISION MADE: 27-MAY-05
P.O. BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM
SYNTHES (USA) 510(k) NO: K050608(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-5868
1302 WRIGHTS LANE EAST SE DECISION MADE: 18-MAY-05
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOG
SYSMEX AMERICA, INC. 510(k) NO: K050589(TRADITIONAL)
ATTN: NINA GAMPERLING PHONE NO : 847-996-4675
ONE NELSON C. WHITE PARKWAY SE DECISION MADE: 04-MAY-05
MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABL
TECHNOMED EUROPE 510(k) NO: K050325(TRADITIONAL)
ATTN: RENE RONCKEN PHONE NO : 314 340 86868
AMERIKALAAN 71 SE DECISION MADE: 05-MAY-05
MAASTRICHT AIRPORT, NETHERLANDS 61510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URITEK 151 URINE ANALYZER, MODEL TC-151
TECO DIAGNOSTICS 510(k) NO: K042421(TRADITIONAL)
ATTN: TONG S CHIAH PHONE NO : 714-693-7788
1268 NORTH LAKEVIEW AVE. SE DECISION MADE: 09-MAY-05
ANAHEIM, CA 92807 510(k) STATEMENT
DEVICE: MODEL TL-560 POWER SCOOTER
TEH LIN PROSTHETIC & ORTHOPAEDIC, 510(k) NO: K051116(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 31-MAY-05
HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL TL-360 POWER SCOOTER
TEH LIN PROSTHETIC & ORTHOPAEDIC, 510(k) NO: K051118(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 31-MAY-05
HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITALWARE VMS
TELEVITAL, INC. 510(k) NO: K050128(TRADITIONAL)
ATTN: GRACE BARTOO PHONE NO : 650-303-0985
409 WALNUT STREET SE DECISION MADE: 13-MAY-05
SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)
TERAKLIN, INC. 510(k) NO: K033262(TRADITIONAL)
ATTN: MARIKA ANDERSON PHONE NO : 818-907-8560
16633 VENTURA BLVD., SUITE 925 SE DECISION MADE: 27-MAY-05
ENCINO, CA 91436 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TISSUE FIXATION SYSTEM
TFS MANUFACTURING PTY LTD 510(k) NO: K050418(TRADITIONAL)
ATTN: ALASTAIR DOWLING PHONE NO : 618 835 10644
18 KINCAID AVENUE SE DECISION MADE: 16-MAY-05
NORTH PLYMPTON SA, AUSTRALIA 5037 510(k) STATEMENT
DEVICE: B-CAD SYSTEM, VERSION 1.0
THE MEDIPATTERN CORPORATION 510(k) NO: K050846(TRADITIONAL)
ATTN: PATRICIA A MILBANK PHONE NO : 416 744 0009
2300 SHEPPARD AVE W SUITE 204 SE DECISION MADE: 26-MAY-05
TORONTO, ON, CANADA M9M 3A4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THEKEN REVEAL VBR SYSTEM
THEKEN SURGICAL,LLC 510(k) NO: K050058(TRADITIONAL)
ATTN: RANDY THEKEN PHONE NO : 330-773-7677
283 E WATERLOO RD. SE DECISION MADE: 17-MAY-05
AKRON, OH 44319 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPID ONE STEP BUPRENORPHINE TEST CARD
TIANJIN NEW BAY BIORESEARCH CO., L510(k) NO: K042988(TRADITIONAL)
ATTN: RODRIGO BERLIE PHONE NO : 858-922-7981
2720 LOKER AVENUE WEST SE DECISION MADE: 12-MAY-05
SUITE U 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92008
DEVICE: FOR SURE ONE STEP BUPRENORPHINE TEST STRIP
TIANJIN NEW BAY BIORESEARCH CO., L510(k) NO: K042990(TRADITIONAL)
ATTN: RODRIGO BERLIE PHONE NO : 858-922-7981
2720 LOKER AVENUE WEST SE DECISION MADE: 10-MAY-05
SUITE U 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92008
DEVICE: VENTANA IMAGE ANALYSIS SYSTEM
TRIPATH IMAGING, INC. 510(k) NO: K050012(TRADITIONAL)
ATTN: BRYAN TUCKER PHONE NO : 919-206-7166
780 PLANTATION DR. SE DECISION MADE: 06-MAY-05
BURLINGTON, NC 27215 510(k) STATEMENT
DEVICE: ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUG
ULTI MED, INC. 510(k) NO: K050464(TRADITIONAL)
ATTN: CAROLE STAMP PHONE NO : 952-746-8080
5353 WAYZATA BLVD., STE 505 SE DECISION MADE: 11-MAY-05
MINNEAPOLIS, MN 55414 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E.P.T. CERTAINTY PREGNANCY TEST
UNIPATH LTD. 510(k) NO: K050930(SPECIAL)
ATTN: LOUISE ROBERTS PHONE NO : 44 123 4835564
PRIORY BUSINESS PARK SE DECISION MADE: 12-MAY-05
BEDFORD, UNITED KINGDOM MK44 3UP 510(k) STATEMENT
DEVICE: UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES
UNIQSAFE BIOMEDITECH CO., LTD. 510(k) NO: K050116(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 09-MAY-05
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED ARTHROSCOPIC WANDS
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K043198(TRADITIONAL)
ATTN: HEATHER CRAWFORD PHONE NO : 863-683-8680
5307 GREAT OAK DR. SE DECISION MADE: 27-MAY-05
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY
VASCULAR SOLUTIONS, INC. 510(k) NO: K050146(TRADITIONAL)
ATTN: LINDA BUSKLEIN PHONE NO : 763-656-4217
6464 SYCAMORE COURT NORTH SE DECISION MADE: 27-MAY-05
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
VASCULAR SOLUTIONS, INC. 510(k) NO: K050168(TRADITIONAL)
ATTN: SARA L COON PHONE NO : 763-656-4300
6464 SYCAMORE COURT NORTH SE DECISION MADE: 18-MAY-05
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREMERE DELIVERY SHEATH, MODEL PDS
VELOCIMED INC. 510(k) NO: K043084(TRADITIONAL)
ATTN: JOHN CARLINE PHONE NO : 763-463-4700
6550 WEDGWOOD RD. NORTH SE DECISION MADE: 02-MAY-05
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55311
DEVICE: ANTI-I.V. ENTERAL FEEDING SYSTEM
VIASYS MEDSYSTEMS 510(k) NO: K043044(TRADITIONAL)
ATTN: STEPHANIE WASIELEWSKI PHONE NO : 847-353-1348
100 CHADDICK DR. SE DECISION MADE: 06-MAY-05
WHEELING, IL 60090 510(k) STATEMENT
DEVICE: VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE
VITALCARE GROUP, INC. 510(k) NO: K040916(TRADITIONAL)
ATTN: MICHAEL MCAVENIA PHONE NO : 305-620-4007
8935 N.W. 27TH ST. SE DECISION MADE: 04-MAY-05
MIAMI, FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WILSON-COOK ENTERAL FEEDING TUBE, "TIGER TUBE" ENTERAL FEEDING T
WILSON-COOK MEDICAL, INC. 510(k) NO: K043203(TRADITIONAL)
ATTN: MARGE WALLS-WALKER PHONE NO : 800-245-4707
4900 BETHANIA STATION RD. SE DECISION MADE: 11-MAY-05
WINSTON-SALEM, NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHT DRAPE
WRAPPED IN COMFORT 510(k) NO: K043234(TRADITIONAL)
ATTN: JANE GETSLA PHONE NO : 877-205-0901
15760 VIA SONATA SE DECISION MADE: 25-MAY-05
SAN LORENZO, CA 94580 510(k) STATEMENT
DEVICE: PROCOTYL-E ACETABULAR SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K043073(TRADITIONAL)
ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732
5677 AIRLINE RD. SE DECISION MADE: 04-MAY-05
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIEHM QUANTUM
ZIEHM IMAGING, INC. 510(k) NO: K051064(TRADITIONAL)
ATTN: RICHARD WESTRICH PHONE NO : 951-781-2020
4181 LATHAM ST. SE DECISION MADE: 26-MAY-05
RIVERSIDE, CA 92501 510(k) STATEMENT
DEVICE: EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
ZIMMER TRABECULAR 510(k) NO: K050766(TRADITIONAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 26-MAY-05
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRABECULAR METAL ACETABULAR REVISION SHELLS
ZIMMER TRABECULAR 510(k) NO: K050937(SPECIAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 11-MAY-05
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS
ZIMMER, INC. 510(k) NO: K050105(TRADITIONAL)
ATTN: BRANDON HIPSHER PHONE NO : 574-372-4485
345 E. MAIN ST. SE DECISION MADE: 17-MAY-05
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES
ZOLL MEDICAL CORPORATION 510(k) NO: K051076(SPECIAL)
ATTN: SEAN REYNOLDS PHONE NO : 978-421-9386
269 MILL ROAD SE DECISION MADE: 13-MAY-05
CHELMSFORD, MA 01824-4105 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 262
TOTAL WITH SUMMARIES 225
TOTAL WITH STATEMENTS 37
Updated June 6, 2005
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