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510(k)s Final Decisions Rendered for June 2003 |
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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-JUN-2003 THROUGH 30-JUN-2003
DEVICE: 3TP SOFTWARE OPTION
3TP LLC 510(k) NO: K031350(TRADITIONAL)
ATTN: VINCENT J MCGILL PHONE NO : 212-561-3604
3 PARK AVE. SE DECISION MADE: 23-JUN-03
NEW YORK, NY 10016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLUTION FACE MASKS
A PLUS INTL., INC. 510(k) NO: K031353(TRADITIONAL)
ATTN: SOLOMON CHEN PHONE NO : 909-548-0890
5138 ECULYPTUS AVE. SE DECISION MADE: 19-JUN-03
CHINO, CA 91710 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS H
ACCESS BIO INCORPORATE 510(k) NO: K031048(TRADITIONAL)
ATTN: YOUNG HO CHOI PHONE NO : 732-246-7400
675 US HIGHWAY 1 SE DECISION MADE: 16-JUN-03
NORTH BRUNSWICK, NJ 08902 510(k) STATEMENT
DEVICE: CARESTART HCG ONE-STEP PREGNANCY TEST
ACCESS BIO INCORPORATE 510(k) NO: K031052(TRADITIONAL)
ATTN: YOUNG HO CHOI PHONE NO : 732-246-7400
675 US HIGHWAY 1 SE DECISION MADE: 13-JUN-03
NORTH BRUNSWICK, NJ 08902 510(k) STATEMENT
DEVICE: SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH
ACMI CORPORATION 510(k) NO: K030684(TRADITIONAL)
ATTN: FRANK FUCILE PHONE NO : 508-804-2600
136 TURNPIKE RD. SE DECISION MADE: 03-JUN-03
SOUTHBOROUGH, MA 01772 510(k) STATEMENT
DEVICE: BERKELEY V-10 VACUUM CURETTAGE SYSTEM
ACMI CORPORATION 510(k) NO: K030935(TRADITIONAL)
ATTN: FRANK FUCILE PHONE NO : 508-804-2617
136 TURNPIKE RD. SE DECISION MADE: 23-JUN-03
SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENS PRO 900
ACUMED MEDICAL SUPPLIES, LTD. 510(k) NO: K023726(TRADITIONAL)
ATTN: RICHARD KEEN PHONE NO : 203-329-2700
1151 HOPE ST. SE DECISION MADE: 17-JUN-03
STANFORD, CT 06907 510(k) STATEMENT
DEVICE: SKYLIGHT IMAGING SYSTEM
ADAC LABORATORIES 510(k) NO: K031705(TRADITIONAL)
ATTN: COLEEN A COLEMAN PHONE NO : 408-468-3051
540 ALDER DR. SE DECISION MADE: 17-JUN-03
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC
ADAC LABORATORIES 510(k) NO: K031872(TRADITIONAL)
ATTN: CHARLENE BRUMBAUGH PHONE NO : 408-468-3619
540 ALDER DR. SE DECISION MADE: 20-JUN-03
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ANTIMICROBIAL ALGINATE DRESSING
ADVANCED MEDICAL SOLUTIONS LTD. 510(k) NO: K024298(TRADITIONAL)
ATTN: JOHN GREEN PHONE NO : 440 160 6863500
ROAD THREE, SE DECISION MADE: 30-JUN-03
WINSFORD INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
WINSFORD, CHESHIRE, UNITED KINGDOM CW7 3PD
DEVICE: AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
AESCULAP, INC. 510(k) NO: K031303(SPECIAL)
ATTN: MATTHEW M HULL PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 04-JUN-03
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCANX 10
AIR TECHNIQUES, INC. 510(k) NO: K031198(TRADITIONAL)
ATTN: JOSEPH CAREY PHONE NO : 516-433-7676
70 CANTIAGUE ROCK RD. SE DECISION MADE: 20-JUN-03
HICKSVILLE, NY 11801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTERIALFLOW SYSTEM, MODEL 32A
AIRCAST, INC. 510(k) NO: K024019(TRADITIONAL)
ATTN: STEPHEN L KENNEY PHONE NO : 908-273-6349
92 RIVER RD. SE DECISION MADE: 03-JUN-03
SUMMIT, NJ 07901 510(k) STATEMENT
DEVICE: PNEUTON VENTILATOR
AIRON CORPORATION 510(k) NO: K024344(TRADITIONAL)
ATTN: G. ERIC GJERDE PHONE NO : 321-723-0019
102 EAST NEW HAVEN AVE. #146 SE DECISION MADE: 03-JUN-03
MELBOURNE, FL 32901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K024360(TRADITIONAL)
ATTN: NAISHU WANG PHONE NO : 858-513-3888
12330 STOWE DR. SE DECISION MADE: 10-JUN-03
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE-STEP PREGNANCY TEST
AMERISOURCE PHARMACAL, INC. 510(k) NO: K031271(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT ST. SE DECISION MADE: 17-JUN-03
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANDIODYNAMICS, INC. ELVS PROCEDURE KIT
ANGIODYNAMICS, INC. 510(k) NO: K031233(TRADITIONAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 18-JUN-03
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
ANGIODYNAMICS, INC. 510(k) NO: K031626(SPECIAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 19-JUN-03
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH
ANGIOMETRX INC. 510(k) NO: K024000(TRADITIONAL)
ATTN: CARL YOUNGMANN PHONE NO : 206-720-1540
936 11TH AVENUE EAST SE DECISION MADE: 26-JUN-03
SEATTLE, WA 98102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZMANAGER PLUS
ANIMAS CORP. 510(k) NO: K022394(TRADITIONAL)
ATTN: MICHAEL J ANDREWS PHONE NO : 610-644-8990
590 E. LANCASTER AVE. SE DECISION MADE: 05-JUN-03
FRAZER, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-1805M
ANODIA SYSTEMS 510(k) NO: K023815(TRADITIONAL)
ATTN: THAD J OVERMYER PHONE NO : 866-246-2548
514 SOUTH THIRD ST. SE DECISION MADE: 19-JUN-03
DANVILLE, KY 40422 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-1890
ANODIA SYSTEMS 510(k) NO: K023896(TRADITIONAL)
ATTN: THAD OVERMYER PHONE NO : 859-236-4778
514 SOUTH THIRD ST. SE DECISION MADE: 19-JUN-03
DANVILLE, KY 40422 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
ARTHROCARE CORP. 510(k) NO: K031029(TRADITIONAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 19-JUN-03
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPH
ASAP ENDOSCOPIC PRODUCTS GMBH 510(k) NO: K031141(TRADITIONAL)
ATTN: MARTINA GUNDEROTH PHONE NO : 49 451 3882864
KATHARINENSTR. 5 SE DECISION MADE: 30-JUN-03
LUEBECK, GERMANY 23554 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED
ASTRA TECH, INC. 510(k) NO: K024111(TRADITIONAL)
ATTN: BRUCE R MANNING PHONE NO : 508-393-3100
96 WEST MAIN ST. SE DECISION MADE: 10-JUN-03
P.O. BOX 809 510(k) SUMMARY AVAILABLE FROM FDA
NORTHBOROUGH, MA 01532
DEVICE: DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K031177(TRADITIONAL)
ATTN: EILEEN MCCAFFERTY PHONE NO : 441 382 422000
THE TECHNOLOGY PARK SE DECISION MADE: 19-JUN-03
DUNDEE, SCOTLAND, UNITED KINGDOM D510(k) STATEMENT
DEVICE: FLUENCY TRACHEOBRONCHIAL STENT GRAFT
BARD PERIPHERAL VASCULAR 510(k) NO: K031041(ABBREVIATED)
ATTN: AYMEE R BERRY PHONE NO : 480-303-2752
1625 WEST 3RD ST. SE DECISION MADE: 19-JUN-03
TEMPE, AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
BAXTER HEALTHCARE CORP. 510(k) NO: K030099(TRADITIONAL)
ATTN: ROBERT L WILKINSON PHONE NO : 847-473-6335
1620 WAUKEGAN RD. SE DECISION MADE: 17-JUN-03
MCGAW PARK, IL 60085 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
BAYER HEALTHCARE, LLC 510(k) NO: K031038(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE. SE DECISION MADE: 23-JUN-03
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER ADVIA CENTAUR CA 19-9 ASSAY
BAYER HEALTHCARE, LLC 510(k) NO: K031393(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE. SE DECISION MADE: 24-JUN-03
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL
BAYER HEALTHCARE, LLC 510(k) NO: K031644(ABBREVIATED)
ATTN: ANDRES HOLLE PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 25-JUN-03
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIPOPROTEIN CALIBRATOR
BAYER HEALTHCARE, LLC 510(k) NO: K031682(ABBREVIATED)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE. SE DECISION MADE: 25-JUN-03
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML
BD DIAGNOSTIC SYSTEMS 510(k) NO: K031429(TRADITIONAL)
ATTN: KATHRYN B POWERS PHONE NO : 410-316-4260
7 LOVETON CIRCLE SE DECISION MADE: 06-JUN-03
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY
BECKMAN COULTER, INC. 510(k) NO: K031506(SPECIAL)
ATTN: LYNN WEIST PHONE NO : 952-368-1271
1000 LAKE HAZELTINE DR. SE DECISION MADE: 02-JUN-03
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
BECKMAN COULTER, INC. 510(k) NO: K031606(SPECIAL)
ATTN: LYNN WEIST PHONE NO : 952-368-1271
1000 LAKE HAZELTINE DR. SE DECISION MADE: 20-JUN-03
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE
BECTON DICKINSON & CO. 510(k) NO: K031200(SPECIAL)
ATTN: CYNTHIA LACATENA PHONE NO : 201-847-6869
1 BECTON DR. SE DECISION MADE: 24-JUN-03
FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD VIPER INSTRUMENT
BECTON, DICKINSON AND COMPANY 510(k) NO: K023955(TRADITIONAL)
ATTN: COLLEN A KISTLER PHONE NO : 410-316-4988
7 LOVETON CIR. SE DECISION MADE: 24-JUN-03
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POS
BECTON, DICKINSON AND COMPANY 510(k) NO: K031306(TRADITIONAL)
ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778
7 LOVETON CIR. SE DECISION MADE: 02-JUN-03
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CURAD SCAR THERAPY
BEIERSDORF, INC. 510(k) NO: K024057(TRADITIONAL)
ATTN: FRANCES K WU PHONE NO : 202-737-4294
700 THIRTEENTH STREET, N.W. SE DECISION MADE: 18-JUN-03
SUITE 1200 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005-5929
DEVICE: SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515
BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K030708(TRADITIONAL)
ATTN: MICHELLE SAWYER PHONE NO : 353 91 774361
BMR HOUSE SE DECISION MADE: 25-JUN-03
PARKMORE BUSINESS PARK WEST 510(k) SUMMARY AVAILABLE FROM FDA
GALWAY, IRELAND
DEVICE: LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URIN
BIO-RAD 510(k) NO: K031231(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 18-JUN-03
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8
BIOFORM, INC. 510(k) NO: K030682(TRADITIONAL)
ATTN: WILLIAM G HUBBARD PHONE NO : 262-835-9800
4133 COURTNEY ROAD, #10 SE DECISION MADE: 27-JUN-03
FRANKSVILLE, WI 53126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM K
BIOLITEC, INC. 510(k) NO: K030700(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST., NW SE DECISION MADE: 04-JUN-03
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1
BIOMEDICAL SYSTEMS CORP. 510(k) NO: K024323(TRADITIONAL)
ATTN: K. MICHAEL KROEHNKE PHONE NO : 314-576-6800
2464 WEST PORT PLAZA DR. SE DECISION MADE: 30-JUN-03
ST. LOUIS, MO 63146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDAS TROPONIN I (TNI), MODEL 30 445
BIOMERIEUX, INC. 510(k) NO: K030950(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695
595 ANGLUM RD. SE DECISION MADE: 16-JUN-03
HAZELWOOD, MO 63042-2320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-MODULAR SHOULDER SYSTEM
BIOMET, INC. 510(k) NO: K030710(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
56 BELL DR. SE DECISION MADE: 04-JUN-03
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: HA PMI FLANGED ACETABULAR COMPONENT
BIOMET, INC. 510(k) NO: K030861(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 12-JUN-03
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
BIONICARE MEDICAL TECHNOLOGIES, IN510(k) NO: K030332(SPECIAL)
ATTN: KENT HOFFMAN PHONE NO : 410-472-1888
47 R LOVETON CIRCLE SE DECISION MADE: 06-JUN-03
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210
BISCO, INC. 510(k) NO: K030951(TRADITIONAL)
ATTN: STEPHEN (STEVE) SMITH PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 06-JUN-03
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE POSTERIOR CERVICAL SYSTEM
BLACKSTONE MEDICAL, INC. 510(k) NO: K030197(TRADITIONAL)
ATTN: DEAN E CIPORKIN PHONE NO : 413-731-8711
90 BROOKSDALE DR. SE DECISION MADE: 12-JUN-03
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFIC
BLACKSTONE MEDICAL, INC. 510(k) NO: K030581(SPECIAL)
ATTN: DEAN E CIPORKIN PHONE NO : 413-731-8711
90 BROOKSDALE DR. SE DECISION MADE: 26-JUN-03
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE SURGICAL TITANIUM MESH
BLACKSTONE MEDICAL, INC. 510(k) NO: K030744(TRADITIONAL)
ATTN: DEAN E CIPORKIN PHONE NO : 413-731-8711
90 BROOKSDALE DR. SE DECISION MADE: 27-JUN-03
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CAVERMAP SURGICAL AID
BLUE TORCH MEDICAL TECHNOLOGIES 510(k) NO: K031527(SPECIAL)
ATTN: FREDERICK TOBIA PHONE NO : 617-618-5105
180 WELLS AVENUE SE DECISION MADE: 05-JUN-03
NEWTON, MA 02459 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFE
BOSTON SCIENTIFIC CORP. 510(k) NO: K031538(SPECIAL)
ATTN: PAIGE SWEENEY PHONE NO : 508-652-5560
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 27-JUN-03
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC
BOSTON SCIENTIFIC EPI 510(k) NO: K023691(TRADITIONAL)
ATTN: TIMOTHY J JOHNSON PHONE NO : 408-970-7343
2525 WALSH AVE. SE DECISION MADE: 04-JUN-03
SANTA CLARA, CA 95051-1316 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTORVISION FLUORO3D
BRAINLAB, AG 510(k) NO: K024192(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9916680
AMMERTHALSTRASSE 8 SE DECISION MADE: 11-JUN-03
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IQMARK DIGITAL HOLTER
BRENTWOOD MEDICAL TECHNOLOGY CORP.510(k) NO: K031466(SPECIAL)
ATTN: RUOMEI ZHANG PHONE NO : 310-530-5955
3300 FUJITA ST. SE DECISION MADE: 11-JUN-03
TORRANCE, CA 90505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDO GATOR SYSTEM
BYRNE MEDICAL, INC. 510(k) NO: K031773(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 832-285-9423
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 24-JUN-03
HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER
C.R. BARD, INC. 510(k) NO: K030020(ABBREVIATED)
ATTN: GLENN NORTON PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 16-JUN-03
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFT
C.R. BARD, INC. 510(k) NO: K031000(TRADITIONAL)
ATTN: DEBORAH L HERRINGTON PHONE NO : 978-323-2216
55 TECHNOLOGY DR. SE DECISION MADE: 03-JUN-03
LOWELL, MA 01851 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
CANON U.S.A., INC. 510(k) NO: K031629(TRADITIONAL)
ATTN: SHEILA DRISCOLL PHONE NO : 516-328-5602
ONE CANON PLAZA SE DECISION MADE: 06-JUN-03
LAKE SUCCESS, NY 11042-1198 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C
CANON U.S.A., INC. 510(k) NO: K031633(TRADITIONAL)
ATTN: SHEILA DRISCOLL PHONE NO : 516-328-5602
ONE CANON PLAZA SE DECISION MADE: 11-JUN-03
LAKE SUCCESS, NY 11042-1198 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TEMPORARY TITANIUM ANEURYSM CLIP
CARDINAL HEALTH 510(k) NO: K031468(TRADITIONAL)
ATTN: LANCE MACRCONI PHONE NO : 847-785-3312
1500 WAUKEGAN ROAD, BLDG. WM SE DECISION MADE: 20-JUN-03
MCGAW PARK, IL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARE ETS
CARE REHAB AND ORTHOPAEDIC 510(k) NO: K023036(TRADITIONAL)
ATTN: CHRISTIAN E HUNT PHONE NO : 703-448-9644
1124 DOMINION CT. SE DECISION MADE: 19-JUN-03
MCLEAN, VA 22102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UFI GEL HARD C
CASCADES DEVICE CONSULTING ASSOCIA510(k) NO: K030916(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 19-JUN-03
BEND, OR 97702-1923 510(k) STATEMENT
DEVICE: AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
CIBA VISION CORP. 510(k) NO: K031521(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 678-415-3897
11460 JOHNS CREEK PKWY. SE DECISION MADE: 27-JUN-03
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLO-CARE PLUS MULTIPURPOSE SOLUTION
CIBA VISION CORP. 510(k) NO: K031522(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 678-415-3897
11460 JOHNS CREEK PKWY. SE DECISION MADE: 27-JUN-03
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500
CLINICAL DATA 510(k) NO: K030528(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 W. LAMBERT RD., SUITE D SE DECISION MADE: 17-JUN-03
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-PORT
CLINISURG VASCULAR PRODUCTS, LLC 510(k) NO: K030636(TRADITIONAL)
ATTN: DONALD F HULTS PHONE NO : 214-691-5935
5454 AMESBURY DR., #2107 SE DECISION MADE: 05-JUN-03
DALLAS, TX 75206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010
CLIO DESIGNS, INC. 510(k) NO: K023817(TRADITIONAL)
ATTN: BERNARD FABRICANT PHONE NO : 617-969-7509
ONE GROVE ST. SE DECISION MADE: 25-JUN-03
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SUR
COMPUTER MOTION, INC. 510(k) NO: K030578(TRADITIONAL)
ATTN: CATHY STUPAK PHONE NO : 805-685-3729
130-B CREMONA DR. SE DECISION MADE: 24-JUN-03
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCB COMPUTER MOTION INTERFACE CONTROLLER
COMPUTER MOTION, INC. 510(k) NO: K030718(TRADITIONAL)
ATTN: KEITH LOWREY PHONE NO : 805-685-3729
130-B CREMONA DR. SE DECISION MADE: 05-JUN-03
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HERMES O.R. CONTROL CENTER
COMPUTER MOTION, INC. 510(k) NO: K031382(SPECIAL)
ATTN: KEITH LOWREY PHONE NO : 805-685-3729
130 CREMONA DRIVE, SUITE B SE DECISION MADE: 30-JUN-03
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARIES INDICATOR
CONFI-DENTAL PRODUCTS CO. 510(k) NO: K030807(TRADITIONAL)
ATTN: STEPHEN RUDOLPH PHONE NO : 303-665-7535
416 SOUTH TAYLOR AVE. SE DECISION MADE: 09-JUN-03
LOUISVILLE, CO 80027-3028 510(k) STATEMENT
DEVICE: ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
COOK, INC. 510(k) NO: K031766(SPECIAL)
ATTN: KAREN BRADBURN PHONE NO : 800-346-2686
750 DANIELS WAY SE DECISION MADE: 26-JUN-03
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402-0489
DEVICE: CORD STICK MULTIPLE DRAW SYSTEM
CORD STICK CORP. 510(k) NO: K031058(TRADITIONAL)
ATTN: MICHAEL MOEN PHONE NO : 209-524-4821
1400 FLORIDA AVE., SUITE 205 SE DECISION MADE: 13-JUN-03
MODESTO, CA 95350 510(k) STATEMENT
DEVICE: MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY
CORDIS CORP. 510(k) NO: K031197(SPECIAL)
ATTN: SAM MIRZA PHONE NO : 786-313-2007
14201 N.W. 60TH AVE. SE DECISION MADE: 16-JUN-03
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO
CORDIS NEUROVASCULAR, INC. 510(k) NO: K030963(TRADITIONAL)
ATTN: ALINA CARABALLO PHONE NO : 786-313-6518
14000 N.W. 57TH CT. SE DECISION MADE: 20-JUN-03
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CP MEDICAL BONE WAX
CP MEDICAL 510(k) NO: K024372(TRADITIONAL)
ATTN: SUE RIDGE PHONE NO : 503-232-1555
836 N.E. 24TH AVE. SE DECISION MADE: 19-JUN-03
PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESQPOD CIRCULATORY ENHANCER
CPRX LLC 510(k) NO: K022906(ABBREVIATED)
ATTN: JOHN F STAPLETON PHONE NO : 952-947-9590
7615 GOLDEN TRIANGLE DR. SE DECISION MADE: 11-JUN-03
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
EDEN PRAIRIE, MN 55344
DEVICE: CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER
CYNOSURE, INC. 510(k) NO: K031488(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 04-JUN-03
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYVA EMIT II PLUS AMPHETAMINES ASSAY
DADE BEHRING, INC. 510(k) NO: K031004(TRADITIONAL)
ATTN: RADAMES RIESGO PHONE NO : 305-480-7558
500 GBC DR. SE DECISION MADE: 06-JUN-03
NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
DADE BEHRING, INC. 510(k) NO: K031135(TRADITIONAL)
ATTN: LORRAINE PIESTRAK PHONE NO : 302-631-6279
P.O. BOX 6101 SE DECISION MADE: 02-JUN-03
GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: "VIRGO", MODEL 9VIR1200
DANISH DIAGNOSTIC DEVELOPMENT A/S 510(k) NO: K031825(ABBREVIATED)
ATTN: NIELS SORENSEN PHONE NO : 45 45 768888
DR. NEERGAARDSVEJ 5F SE DECISION MADE: 20-JUN-03
HORSHOLM, DENMARK 2970 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
DATASCOPE CORP. 510(k) NO: K031569(SPECIAL)
ATTN: JOANN TAYLOR PHONE NO : 973-244-6100
15 LAW DR. SE DECISION MADE: 10-JUN-03
FAIRFIELD, NJ 07004-0011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR
DATEX-OHMEDA 510(k) NO: K030990(TRADITIONAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM RD. SE DECISION MADE: 25-JUN-03
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA HMEF 750
DATEX-OHMEDA 510(k) NO: K031653(SPECIAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685
86 PILGRIM RD. SE DECISION MADE: 20-JUN-03
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSOR
DATEX-OHMEDA 510(k) NO: K031781(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM RD. SE DECISION MADE: 25-JUN-03
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)
DATEX-OHMEDA, INC. 510(k) NO: K031027(SPECIAL)
ATTN: WILLIAM E EXNER PHONE NO : 608-221-1551
OHMEDA DR. SE DECISION MADE: 26-JUN-03
P.O. BOX 7550 510(k) SUMMARY AVAILABLE FROM FDA
MADISON, WI 53707-7550
DEVICE: AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (
DATEX-OHMEDA, INC. 510(k) NO: K031479(SPECIAL)
ATTN: AL VAN HOUDT PHONE NO : 425-657-7200
5150 220TH AVE SE SE DECISION MADE: 06-JUN-03
ISSAQUAH, WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEMETECH NYLON NONABSORBABLE SUTURE
DEMETECH CORP. 510(k) NO: K023028(TRADITIONAL)
ATTN: LUIS ARGUELLO PHONE NO : 305-251-2700
12119 SW 131 AVE. SE DECISION MADE: 18-JUN-03
MIAMI, FL 33186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEMETECH POLYESTER NONABSORBABLE SUTURE
DEMETECH CORP. 510(k) NO: K023030(TRADITIONAL)
ATTN: LUIS ARGUELLO PHONE NO : 305-251-2700
12119 SW 131 AVE. SE DECISION MADE: 18-JUN-03
MIAMI, FL 33186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRP-LATEX (II)X2 SEIKEN ASSAY KIT
DENKA SEIKEN CO., LTD. 510(k) NO: K030545(TRADITIONAL)
ATTN: TOSHIMI MATSUNAGA PHONE NO : 025 042 7221
KAGAMIDA FACILITY SE DECISION MADE: 02-JUN-03
1-2-2 MINAMIHONCHO, 510(k) SUMMARY AVAILABLE FROM FDA
GOSEN CITY, NIIGATA, JAPAN 959-1695
DEVICE: CRP (II) CALIBRATORS
DENKA SEIKEN CO., LTD. 510(k) NO: K030546(TRADITIONAL)
ATTN: TOSHIMI MATSUNAGA PHONE NO : 025 042 7212
KAGAMIDA FACILITY SE DECISION MADE: 02-JUN-03
1-2-2 MINAMIHONCHO, 510(k) SUMMARY AVAILABLE FROM FDA
GOSEN CITY, NIIGATA, JAPAN 959-1695
DEVICE: CONTEC LIGHT
DENTAURUM 510(k) NO: K030641(TRADITIONAL)
ATTN: JAN W A. DOORSCHODT PHONE NO : 215-968-2858
10 PHEASANT RUN SE DECISION MADE: 10-JUN-03
NEWTOWN, PA 18940 510(k) STATEMENT
DEVICE: DEPUY ACROMED VBR SYSTEM
DEPUY ACROMED 510(k) NO: K031635(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 23-JUN-03
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K031495(SPECIAL)
ATTN: KARLA A HAM PHONE NO : 574-371-4925
700 ORTHOPAEDIC DR. SE DECISION MADE: 11-JUN-03
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: ULTRA HIGH PRESSURE INJECTOR LINES
DEROYAL INDUSTRIES, INC. 510(k) NO: K023591(TRADITIONAL)
ATTN: GRACIE GREENWAY PHONE NO : 865-362-1025
200 DEBUSK LN. SE DECISION MADE: 18-JUN-03
POWELL, TN 37849 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE
DIAMETRICS MEDICAL, INC. 510(k) NO: K030035(TRADITIONAL)
ATTN: NANCY RING PHONE NO : 651-638-1250
2658 PATTON RD. SE DECISION MADE: 25-JUN-03
ROSEVILLE, MN 55113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALIBRATING MATERIAL, CALIBRATING STANDARDS
DIAMOND DIAGNOSTICS, INC. 510(k) NO: K031159(TRADITIONAL)
ATTN: LINDA M STUNDTNER PHONE NO : 508-429-0450
331 FISKE ST. SE DECISION MADE: 25-JUN-03
HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRADWEB BY DYNAMIC IMAGING, INC.
DYNAMIC IMAGING INC. 510(k) NO: K031311(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1100 LAKEVIEW BLVD. SE DECISION MADE: 20-JUN-03
DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
E-Z-EM, INC. 510(k) NO: K031571(SPECIAL)
ATTN: STEVEN HARTMAN PHONE NO : 516-333-8230
717 MAIN ST. SE DECISION MADE: 19-JUN-03
WESTBURY, NY 11590 510(k) STATEMENT
DEVICE: EBI P148 SPINAL FIXATION SYSTEM
EBI, L.P. 510(k) NO: K031423(TRADITIONAL)
ATTN: JON CAPARETTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 27-JUN-03
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI XFIX DFS SYSTEM
EBI, L.P. 510(k) NO: K031645(SPECIAL)
ATTN: ART KAUFMAN PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 25-JUN-03
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K030944(TRADITIONAL)
ATTN: JASON SMITH PHONE NO : 949-250-2662
ONE EDWARDS WAY SE DECISION MADE: 20-JUN-03
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES
ELETROMED, INC. 510(k) NO: K030800(TRADITIONAL)
ATTN: LYDIA BAYNES PHONE NO : 866-378-4672
4938 HAMDEN LN. #750 SE DECISION MADE: 11-JUN-03
BETHEDA, MD 20814 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVES
ELITE INTERNATIONAL, INC. 510(k) NO: K031113(TRADITIONAL)
ATTN: BOBBY LING PHONE NO : 800-788-9486
18709 GREENBAY DR. SE DECISION MADE: 10-JUN-03
ROWLAND HEIGHTS, CA 91748 510(k) STATEMENT
DEVICE: ETI BIPOLAR HEMOSTATIC PROBE
ENDO-THERAPEUTICS, INC. 510(k) NO: K031026(TRADITIONAL)
ATTN: TODD ADKISSON PHONE NO : 727-726-2446
1183 CEDAR ST. SE DECISION MADE: 27-JUN-03
SAFETY HARBOR, FL 34695-2908 510(k) STATEMENT
DEVICE: ORIA CLARIS
EUROSURGICAL S.A. 510(k) NO: K023378(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LN. SUITE C-100 SE DECISION MADE: 27-JUN-03
PLEASANT HILL, CA 94529 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03
EUROSURGICAL S.A. 510(k) NO: K031452(SPECIAL)
ATTN: KEREN E WARDEN PHONE NO : 304-598-0525
7000 HAMPTON CENTER SE DECISION MADE: 18-JUN-03
SUITE G1 510(k) SUMMARY AVAILABLE FROM FDA
MORGANTOWN, WV 26505
DEVICE: NITREX NITINOL GUIDEWIRE
EV3 CORPORATION 510(k) NO: K031864(SPECIAL)
ATTN: CAROLYN ANDERSON PHONE NO : 763-398-7487
4600 NATHAN LN. SE DECISION MADE: 24-JUN-03
PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K023559(TRADITIONAL)
ATTN: KEVIN SHERLOCK PHONE NO : 649 574 0100
P.O BOX 14-348 SE DECISION MADE: 12-JUN-03
PANMURE, AUCKLAND, NEW ZEALAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINGLE USE ORAL MASK, MODEL HC455A
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K023670(TRADITIONAL)
ATTN: ROBERT PETRY PHONE NO : 011 649 5740100
15 MAURICE PAYKEL PLACE SE DECISION MADE: 12-JUN-03
EAST TAMAKI, AUCKLAND, NEW ZEALAND510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERA
FOX HOLLOW TECHNOLOGIES 510(k) NO: K024243(TRADITIONAL)
ATTN: SUZON LOMMEL PHONE NO : 650-568-2521
300 SAGINAW DR. SE DECISION MADE: 20-JUN-03
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GALIX PACESTAR
GALIX BIOMEDICAL INSTRUMENTATION, 510(k) NO: K023080(TRADITIONAL)
ATTN: JORDAN GAVRIELIDES PHONE NO : 305-534-5905
2555 COLLINS AVE., C-5 SE DECISION MADE: 11-JUN-03
MIAMI BEACH, FL 33140 510(k) STATEMENT
DEVICE: ASYRA
GALLOWAY TECHNOLOGIES, LLC 510(k) NO: K023355(TRADITIONAL)
ATTN: JOE GALLOWAY PHONE NO : 801-766-3929
3736 PANARAMA DR. SE DECISION MADE: 24-JUN-03
SARATOGA SPRINGS, UT 84043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOBONE
GE MEDICAL SYSTEMS EUROPE 510(k) NO: K031871(TRADITIONAL)
ATTN: LARRY KROGER PHONE NO : 262 544 3894
283, RUE DE LA MINIERE, B.P.34 SE DECISION MADE: 20-JUN-03
BUC CEDEX, FRANCE 78533 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GE VIVID 7, MODEL FC0003XX
GENERAL ELECTRIC CO. 510(k) NO: K031663(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
P.O. BOX 414 SE DECISION MADE: 09-JUN-03
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENICON LAPAROSCOPES
GENICON, LC 510(k) NO: K030174(TRADITIONAL)
ATTN: GARY HABERLAND PHONE NO : 321-297-1189
P.O. BOX 780038 SE DECISION MADE: 19-JUN-03
ORLANDO, FL 32878-0038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100
GENTEEL TECHNOLOGY CO., LTD. 510(k) NO: K022926(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 06-JUN-03
FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOBAG, MODEL HBBSD2000
GLOBAL BLOOD RESOURCES, LLC 510(k) NO: K031150(TRADITIONAL)
ATTN: KEITH SAMOLYK PHONE NO : 800-942-9243
998 WINDSOR AVE. SE DECISION MADE: 23-JUN-03
WINDSOR, CT 06095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TS3 TUBING SET
GLOBAL BLOOD RESOURCES, LLC 510(k) NO: K031151(TRADITIONAL)
ATTN: KEITH SAMOLYK PHONE NO : 800-942-9243
998 WINDSOR AVE. SE DECISION MADE: 26-JUN-03
WINDSOR, CT 06095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUSTAIN SPACER
GLOBUS MEDICAL INC. 510(k) NO: K031302(TRADITIONAL)
ATTN: DANIEL S PAUL PHONE NO : 610-994-3164
303 SCHELL LN. SE DECISION MADE: 27-JUN-03
PHOENIXVILLE, PA 19460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED VINYL EXAM GLOVES, WHITE
GLORMED INTL., INC. 510(k) NO: K031104(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 10-JUN-03
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPIDO CUT-AWAY GUIDING CATHETER
GUIDANT CORPORATION 510(k) NO: K031505(SPECIAL)
ATTN: SHAH M HILALI PHONE NO : 651-582-7752
4100 HAMLINE AVE NORTH SE DECISION MADE: 25-JUN-03
ST PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYNE IDEAS MINITAPE RP DEVICE
GYNE IDEAS LTD. 510(k) NO: K023898(TRADITIONAL)
ATTN: LOUIS MAZZARESE PHONE NO : 203-254-3565
150 ARAN HILL RD. SE DECISION MADE: 18-JUN-03
FAIRFIELD, CT 06824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM
H & W TECHNOLOGY, LLC 510(k) NO: K014013(ABBREVIATED)
ATTN: CHARLES O HANCOCK PHONE NO : 585-223-1850
P.O. BOX 20281 SE DECISION MADE: 25-JUN-03
ROCHESTER, NY 14602-0281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAP DISC 120 X 120MM X2CM, MODEL LD111, LAP DISC 120 X 120MMX 7C
HAKKO MEDICAL CO., LTD. 510(k) NO: K030824(TRADITIONAL)
ATTN: ELIZABETH MILLER PHONE NO : 513-337-7146
4545 CREEK RD. SE DECISION MADE: 04-JUN-03
CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODE
HAND BIOMECHANICS LAB, INC. 510(k) NO: K030519(TRADITIONAL)
ATTN: TIMOTHY R STALLINGS PHONE NO : 916-923-5073
77 SCRIPPS DR., SUITE 104 SE DECISION MADE: 10-JUN-03
SACRAMENTO, CA 95825 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS
HANS RUDOLPH, INC. 510(k) NO: K030822(TRADITIONAL)
ATTN: KEVIN RUDOLPH PHONE NO : 816-363-5522
7200 WYANDOTTE SE DECISION MADE: 03-JUN-03
KANSAS CITY, MO 64114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT
HEALEX PRODUCTS, INC. 510(k) NO: K030727(TRADITIONAL)
ATTN: MILTON HODOSH PHONE NO : 401-781-3223
243 ELMWOOD AVE. SE DECISION MADE: 05-JUN-03
PROVIDENCE, RI 02907 510(k) STATEMENT
DEVICE: RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2
HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K031101(ABBREVIATED)
ATTN: JOSE MONTANEZ PHONE NO : 443-367-5518
9033 RED BRANCH RD. SE DECISION MADE: 16-JUN-03
COLUMBIA, MD 21045 510(k) STATEMENT
DEVICE: HEMCON BANDAGE OTC; HEMCON CATH/AID
HEMCON, INC. 510(k) NO: K030946(TRADITIONAL)
ATTN: JAMES F HENSEL PHONE NO : 503-245-0459
10575 SW CASCADE AVE. SE DECISION MADE: 19-JUN-03
SUITE 130 510(k) SUMMARY AVAILABLE FROM FDA
TIGARD, OR 97223
DEVICE: HOBBS MISTIFIER SPRAY CATHETER
HOBBS MEDICAL, INC. 510(k) NO: K030765(TRADITIONAL)
ATTN: ROB WHALEN PHONE NO : 860-684-0030
8 SPRING ST. SE DECISION MADE: 09-JUN-03
P.O. BOX 46 510(k) STATEMENT
STAFFORD SPRINGS, CT 06076
DEVICE: VMATE MODEL VMM1000
HOWARD INSTRUMENTS, INC. 510(k) NO: K030948(TRADITIONAL)
ATTN: JACK HOWARD PHONE NO : 205-553-4453
4749 APPLETREE LN. SE DECISION MADE: 17-JUN-03
TUSCALOOSA, AL 35405-5747 510(k) STATEMENT
DEVICE: RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016
ICN BIOMEDICALS, INC. 510(k) NO: K030211(TRADITIONAL)
ATTN: CHARKES C.F. YU PHONE NO : 650-558-0395
1429 ROLLINS RD. SE DECISION MADE: 13-JUN-03
BURLINGAME, CA 94010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NLITE SYSTEM, MODEL#: A00-1025/A00-1033
ICN PHOTONICS LTD. 510(k) NO: K024189(TRADITIONAL)
ATTN: MIKE KIERMAN PHONE NO : 441 554 755444
UNITS 1&2 HEOL RHOSYN, SE DECISION MADE: 20-JUN-03
DAFEN PARK 510(k) SUMMARY AVAILABLE FROM FDA
LLANELLI, UNITED KINGDOM SA148QG
DEVICE: INION OTPS BIODEGRADABLE FIXATON SYSTEM
INION LTD. 510(k) NO: K030900(TRADITIONAL)
ATTN: HANNA MARTTILA PHONE NO : 358 323 06600
LAAKARINKATU 2 SE DECISION MADE: 19-JUN-03
TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEKTROGEL, MODEL LK3001
INMED LTDA. 510(k) NO: K030887(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 770-777-4146
1308 MORNINGSIDE PARK DR. SE DECISION MADE: 13-JUN-03
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA PLEX ENA PROFILE 6
INOVA DIAGNOSTICS, INC. 510(k) NO: K031450(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 858-586-9900
10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 25-JUN-03
SAN DIEGO, CA 92131-1234 510(k) STATEMENT
DEVICE: CALIBRATION PLASMA LMW HEPARIN
INSTRUMENTATION LABORATORY CO. 510(k) NO: K030964(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 06-JUN-03
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTROL PLASMA LMW HEPARIN
INSTRUMENTATION LABORATORY CO. 510(k) NO: K030965(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 06-JUN-03
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO IVS INTRODUCER SET, MODEL 1003
INTEGRATED VASCULAR SYSTEMS, INC. 510(k) NO: K031583(SPECIAL)
ATTN: SUSAN TURNER PHONE NO : 408-328-9090
743 NORTH PASTORIA AVE. SE DECISION MADE: 16-JUN-03
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TRANSPORT INCUBATOR 185
INTERNATIONAL BIOMEDICS, INC. 510(k) NO: K031096(SPECIAL)
ATTN: GERALD MANNING PHONE NO : 512-973-0033
8508 CROSS PARK DR. SE DECISION MADE: 24-JUN-03
AUSTIN, TX 78754 510(k) STATEMENT
DEVICE: CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,C
INTERSURGICAL, INC. 510(k) NO: K024270(TRADITIONAL)
ATTN: THOMAS R GUNERMAN PHONE NO : 315-451-2900
417 ELECTRONICS PKWY. SE DECISION MADE: 24-JUN-03
LIVERPOOL, NY 13088 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KAISHOU VAGINAL SPECULUM
JIANGSU KAISHOU MEDICAL APPARATUS 510(k) NO: K030761(TRADITIONAL)
ATTN: GONG BO PHONE NO : 008 602 164957283
600 LIU ZHOU ROAD SE DECISION MADE: 09-JUN-03
8 BUILDING, 503 ROOM 510(k) STATEMENT
SHANGHAI, CHINA 200233
DEVICE: JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900
JOMED, INC. 510(k) NO: K031346(SPECIAL)
ATTN: LORRY W HUFFMAN PHONE NO : 800-228-4728
2870 KILGORE RD. SE DECISION MADE: 23-JUN-03
RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ
KAMIYA BIOMEDICAL CO. 510(k) NO: K030687(TRADITIONAL)
ATTN: BRIAN SCHLIESMAN PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 27-JUN-03
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
KARL STORZ ENDOSCOPY 510(k) NO: K030848(TRADITIONAL)
ATTN: PAUL S LEE PHONE NO : 800-421-0837
600 CORPORATE POINTE SE DECISION MADE: 02-JUN-03
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX ELECTRIC HANDPIECE SYSTEM
LARES RESEARCH, INC. 510(k) NO: K031540(TRADITIONAL)
ATTN: JOHN DAHLGREN PHONE NO : 530-345-1767
295 LOCKHEED AVE. SE DECISION MADE: 30-JUN-03
CHICO, CA 95973 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ULTRABLATOR ELECTRODE
LINVATEC CORP. 510(k) NO: K030720(TRADITIONAL)
ATTN: LAURA D SENEFF PHONE NO : 727-399-5234
11311 CONCEPT BLVD. SE DECISION MADE: 03-JUN-03
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3-CCD DIGITAL CAMERA SYSTEM
LINVATEC CORP. 510(k) NO: K031098(TRADITIONAL)
ATTN: LAURA D SENEFF PHONE NO : 727-399-5234
11311 CONCEPT BLVD. SE DECISION MADE: 04-JUN-03
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS
LSI SOLUTIONS 510(k) NO: K031443(ABBREVIATED)
ATTN: CHRISTOPHER A KLACZYK PHONE NO : 585-869-6634
7796 VICTOR-MENDON RD. SE DECISION MADE: 18-JUN-03
VICTOR, NY 14564 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMEND FRONTRUNNER GW CTO CATHETER
LUMEND, INC. 510(k) NO: K031005(SPECIAL)
ATTN: MICHAEL A DANIEL PHONE NO : 415-407-0223
400 CHESAPEAKE DR. SE DECISION MADE: 18-JUN-03
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBIN
LUMENIS, LTD. 510(k) NO: K024093(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 925-895-1200
2400 CONDENSA ST. SE DECISION MADE: 19-JUN-03
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAF
M.K. MEDITECH CO. LTD. 510(k) NO: K031594(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 06-JUN-03
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000
MED-TEC,INC. 510(k) NO: K021360(TRADITIONAL)
ATTN: DONALD F RIIBE PHONE NO : 712-737-8688
1401 8TH ST. S.E. SE DECISION MADE: 10-JUN-03
P.O. BOX 320 510(k) STATEMENT
ORANGE CITY, IA 51041
DEVICE: MEDELA PUMP IN STYLE ADVANCED BREASTPUMP
MEDELA, INC. 510(k) NO: K031614(TRADITIONAL)
ATTN: CHRISTOPHER L PETERSON PHONE NO : 815-363-1166
1101 CORPORATE DR. SE DECISION MADE: 06-JUN-03
MCHENRY, IL 60050-7005 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SYNVITRO HYADASE
MEDI-CULT A/S 510(k) NO: K031228(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751
9915 CAM. CHIRIMOLLA SE DECISION MADE: 24-JUN-03
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLASTFREEZE AND BLASTTHAW
MEDI-CULT A/S 510(k) NO: K031486(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751
9915 CAM. CHIRIMOLLA SE DECISION MADE: 27-JUN-03
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PER, MODEL MEMO
MEDICAL MONITORS PTY., LTD. 510(k) NO: K030218(TRADITIONAL)
ATTN: HARRY L PLATT PHONE NO : 612 934 48100
SUITE 407, OFFICE TOWERS SE DECISION MADE: 23-JUN-03
EAST GARDENS, NSW, AUSTRALIA 2036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOVIEW PRO BY MEDISON CO., LTD.
MEDISON CO., LTD. 510(k) NO: K031886(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1100 LAKEVIEW BLVD. SE DECISION MADE: 30-JUN-03
DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MSD CABLE REDUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K030816(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 06-JUN-03
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K031888(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 27-JUN-03
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K031655(SPECIAL)
ATTN: RICHARD W TREHARNE, PHD PHONE NO : 901-344-1124
1800 PYRAMID PLACE SE DECISION MADE: 27-JUN-03
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO COLORADO 2 SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K030875(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 24-JUN-03
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANTAGE ANTERIOR FIXATION SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K031533(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 13-JUN-03
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIM-SPINE
MEDTRONIC XOMED 510(k) NO: K031510(TRADITIONAL)
ATTN: MARTIN SARGENT PHONE NO : 904-434-7487
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 18-JUN-03
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PRIME ECG SYSTEM
MERIDIAN MEDICAL TECHNOLOGIES, INC510(k) NO: K030104(TRADITIONAL)
ATTN: JAMIL LAHAM PHONE NO : 443-259-8810
10240 OLD COLUMBIA RD. SE DECISION MADE: 11-JUN-03
COLUMBIA, MD 21030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CTXA HIP EXTENDED REFERENCE DATA
MINDWAYS SOFTWARE, INC. 510(k) NO: K030330(TRADITIONAL)
ATTN: CHRISTOPHER CANN PHONE NO : 415-247-9930
282 SECOND ST., 4TH FL. SE DECISION MADE: 20-JUN-03
SAN FRANCISCO, CA 94105-3130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PAR
MINIMED, INC. 510(k) NO: K030531(TRADITIONAL)
ATTN: GERDA P RESCH PHONE NO : 818-362-5958
18000 DEVONSHIRE ST. SE DECISION MADE: 17-JUN-03
NORTHRIDGE, CA 91325 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSULTIVA REPORT STATION, MODEL RS-1
MIRAMEDICA, INC 510(k) NO: K031248(TRADITIONAL)
ATTN: WIDO MENHARDT PHONE NO : 408-858-0718
15466 LOS GATOS BLVD. SE DECISION MADE: 20-JUN-03
SUITE 109, PMB #171 510(k) SUMMARY AVAILABLE FROM FDA
LOS GATOS, CA 95032
DEVICE: MINILOK QUICKANCHOR PLUS
MITEK WORLDWIDE 510(k) NO: K030995(TRADITIONAL)
ATTN: RUTH C FORSTADT PHONE NO : 781-251-3188
249 VANDERBILT AVE. SE DECISION MADE: 26-JUN-03
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUFFLOK ANCHOR
MITEK WORLDWIDE 510(k) NO: K031519(SPECIAL)
ATTN: RUTH C FORSTADT PHONE NO : 781-251-3188
A JOHNSON & JOHNSON COMPANY SE DECISION MADE: 06-JUN-03
249 VANDERBILT AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NORWOOD, MA 02062
DEVICE: KLINIDRAPE SURGICAL DRAPES
MOLNLYCKE HEALTH CARE 510(k) NO: K031131(TRADITIONAL)
ATTN: LINDA A HENDRICKS PHONE NO : 267-685-2078
826 NEWTON YARDLEY RD. SE DECISION MADE: 10-JUN-03
NEWTON, PA 18940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NANMA VACUUM PUMP
NANMA MFG CO., LTD. 510(k) NO: K030913(TRADITIONAL)
ATTN: YOLANDA SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 03-JUN-03
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: NANO-TICROWN
NANO-WRITE CORP. 510(k) NO: K031627(TRADITIONAL)
ATTN: KENNETH E KNAPP PHONE NO : 925-606-1388
2021 LAS POSITAS COURT SE DECISION MADE: 11-JUN-03
SUITE 121 510(k) SUMMARY AVAILABLE FROM FDA
LIVERMORE, CA 94551 THIRD PARTY REVIEW
DEVICE: DETECTAR, MODEL N123-MI
NEKS TECHNOLOGIES 510(k) NO: K023367(TRADITIONAL)
ATTN: CHARLES H KYPER PHONE NO : 919-960-0049
103 NOLEN LN. SE DECISION MADE: 25-JUN-03
CHAPEL HILL, NC 27516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300
NEW STAR LASERS, INC. 510(k) NO: K024259(TRADITIONAL)
ATTN: DONALD V JOHNSON PHONE NO : 916-677-1912
9085 FOOTHILLS BLVD. SE DECISION MADE: 20-JUN-03
ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMART BAG MO
O-TWO SYSTEMS INTERNATIONAL INC. 510(k) NO: K021328(TRADITIONAL)
ATTN: KEVIN BOWDEN PHONE NO : 905 677 9410
7575 KIMBEL ST. SE DECISION MADE: 26-JUN-03
MISSISSAUGA,ONTARIO, CANADA L5S 1C510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE M2-PE MICROKERATOME BLADES
OASIS MEDICAL, INC. 510(k) NO: K030401(TRADITIONAL)
ATTN: YVONNE FERNANDEZ PHONE NO : 909-305-5400
512 S. VERMONT AVE. SE DECISION MADE: 19-JUN-03
GLENDORA, CA 91740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HF MODULE WITH TRANSDUCERS
OPHTHALMIC TECHNOLOGIES, INC. 510(k) NO: K031391(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 RT 17 S SE DECISION MADE: 20-JUN-03
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500
OPUS MEDICAL, INC. 510(k) NO: K031083(TRADITIONAL)
ATTN: JAMES W HART PHONE NO : 949-234-0400
27127 CALLE ARROYO, SUITE 1924 SE DECISION MADE: 12-JUN-03
SAN JUAN CAPISTRANO, CA 92675 510(k) STATEMENT
DEVICE: PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV
OSCOR INC. 510(k) NO: K031164(SPECIAL)
ATTN: MILA DOCKOCIL PHONE NO : 727-937-2511
3816 DE SOTO BLVD. SE DECISION MADE: 19-JUN-03
PALM HARBOR, FL 34683 510(k) STATEMENT
DEVICE: OSMONICS SOLUTION DELIVERY SYSTEM, OZONE GENERATOR
OSMONICS MEDICAL SYSTEMS 510(k) NO: K023011(TRADITIONAL)
ATTN: KRISTINE KALISZEWSKI PHONE NO : 253-395-2200
7848 S. 202ND ST. SE DECISION MADE: 26-JUN-03
KENT, WA 98032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTI BONE CEMENT PLUG
OSTEOIMPLANT TECHNOLOGY, INC. 510(k) NO: K030608(TRADITIONAL)
ATTN: SAM SON PHONE NO : 410-785-0700
11201 PEPPER RD. SE DECISION MADE: 12-JUN-03
HUNT VALLEY, MD 21031-1201 510(k) STATEMENT
DEVICE: PALOMAR LIGHTCUBE
PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K024179(TRADITIONAL)
ATTN: MARCY MOORE PHONE NO : 919-363-2432
131 KELEKENT LN. SE DECISION MADE: 04-JUN-03
CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBV VCA-P18 IGG ELISA
PANBIO LIMITED 510(k) NO: K030863(TRADITIONAL)
ATTN: HELEN JENNINGS PHONE NO : 61 7 33571177
116 LUTWYCHE RD. SE DECISION MADE: 27-JUN-03
WINDSOR, BRISBANE, AUSTRALIA 4030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCO MIC AND MIC/ID PANELS (ERTAPENEM)
PASCO LABORATORIES, INC. 510(k) NO: K031103(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 303-423-9504
12750 WEST 42ND AVE. SE DECISION MADE: 12-JUN-03
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCO MIC AND MIC/ID PANELS
PASCO LABORATORIES, INC. 510(k) NO: K031205(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 303-423-9504
12750 WEST 42ND AVE. SE DECISION MADE: 13-JUN-03
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTACT LENS STORAGE CASE
PELICAN PRODUCTS 510(k) NO: K030987(TRADITIONAL)
ATTN: CAROL NOBEL PHONE NO : 970-245-4091
611 EISENHAUER ST. SE DECISION MADE: 12-JUN-03
GRAND JUNCTION, CO 81505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10
PEREGRINE SURGICAL LTD. 510(k) NO: K031023(TRADITIONAL)
ATTN: TODD RICHMOND PHONE NO : 215-348-0456
51 BRITAIN DR. SE DECISION MADE: 27-JUN-03
NEW BRITAIN, PA 18901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K031021(TRADITIONAL)
ATTN: JAMES F LOGAN PHONE NO : 410-837-1751
1301 DEFENCE HIGHWAY SE DECISION MADE: 13-JUN-03
GAMBRILLS, MD 21034 510(k) STATEMENT
DEVICE: POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED)
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K031414(TRADITIONAL)
ATTN: JAMES F LOGAN PHONE NO : 410-793-0484
1301 DEFENCE HIGHWAY SE DECISION MADE: 26-JUN-03
GAMBRILLS, MD 21034 510(k) STATEMENT
DEVICE: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORE
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K031591(TRADITIONAL)
ATTN: JAMES F LOGAN PHONE NO : 410-837-1751
1301 DEFENCE HIGHWAY SE DECISION MADE: 26-JUN-03
GAMBRILLS, MD 21034 510(k) STATEMENT
DEVICE: PHILIPS EASYDIAGNOST ELEVA
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K031535(SPECIAL)
ATTN: LYNN T HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 17-JUN-03
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98021-3003
DEVICE: SENSE BODY COIL
PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K031095(TRADITIONAL)
ATTN: DUANE C PRASCHAN PHONE NO : 440-483-5743
595 MINER RD. SE DECISION MADE: 20-JUN-03
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNILUX BLUE
PHOTO THERAPEUTICS LIMITED 510(k) NO: K030883(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LN. SE DECISION MADE: 18-JUN-03
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMO
PLEASURE LATEX PRODUCTS SDN. BHD. 510(k) NO: K023333(ABBREVIATED)
ATTN: KOI-YONG LIM PHONE NO : 603 326 40784
LOT 1365, 17TH MILES, JALAN SE DECISION MADE: 23-JUN-03
SUNGAI SEMBILANG 510(k) STATEMENT
JERAM, SELANGOR, MALAYSIA 45800
DEVICE: PLUS ORTHOPEDICS CEMENTED HIP STEM
PLUS ORTHOPEDICS 510(k) NO: K031165(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 06-JUN-03
ROUND ROCK, TX 78681-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS
PORTEX LTD. 510(k) NO: K031622(TRADITIONAL)
ATTN: STEVE OGILVIE PHONE NO : 004 413 03260551
MILITARY ROAD SE DECISION MADE: 26-JUN-03
HYTHE, KENT 510(k) SUMMARY AVAILABLE FROM FDA
ENGLAND CT21 6DB, UNITED KINGDOM
DEVICE: SPECTRAPULSE
PRIMARY TECHNOLOGY, LLC. 510(k) NO: K031680(TRADITIONAL)
ATTN: STEPHEN ALMEIDA PHONE NO : 813-288-0261
813 S. WESTSHORE BLVD. SE DECISION MADE: 24-JUN-03
TAMPA, FL 33609 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES
PRIMUS GLOVES PRIVATE LTD. 510(k) NO: K030444(TRADITIONAL)
ATTN: JOSEPH J.E. PEREIRA PHONE NO : 914 842 413063
PLOT NO:14-A COCHIN SPECIAL SE DECISION MADE: 05-JUN-03
ECONOMIC ZONE 510(k) STATEMENT
KAKKANAD, KOCHI, KERALA, INDIA 682 030
DEVICE: POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTE
PRIMUS GLOVES PRIVATE LTD. 510(k) NO: K030445(TRADITIONAL)
ATTN: JOSEPH J.E. PEREIRA PHONE NO : 91 484 2413063
14-A, COCHIN SPECIAL ECONOMIC SE DECISION MADE: 05-JUN-03
ZONE 510(k) STATEMENT
KAKKANAD, COCHIN, KERALA, INDIA 682037
DEVICE: PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM
PRIZM MEDICAL, INC. 510(k) NO: K024181(TRADITIONAL)
ATTN: CATHRYN N CAMBRIA PHONE NO : 770-396-5909
5536 TROWBRIDGE DR. SE DECISION MADE: 26-JUN-03
DUNWOODY, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URINARY CATHETERS
PROMEDIC, INC. 510(k) NO: K031409(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780
6329 WEST WATERVIEW CT. SE DECISION MADE: 17-JUN-03
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE
PT. MANDIRI INTI BUANA 510(k) NO: K031754(TRADITIONAL)
ATTN: NG POY SIN PHONE NO : 62 61 4566506
JL. LISTRIK NO. 6 SE DECISION MADE: 30-JUN-03
MEDAN, INDONESIA 20112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)
QC SCIENCES, LLC 510(k) NO: K023335(TRADITIONAL)
ATTN: JUNQI QIAN PHONE NO : 804-288-6564
2807 N. PARHAM SE DECISION MADE: 18-JUN-03
SUITE 114 510(k) SUMMARY AVAILABLE FROM FDA
RICHMOND, VA 23294
DEVICE: EKGCARD SYSTEM
QRS DIAGNOSTIC, LLC. 510(k) NO: K030535(TRADITIONAL)
ATTN: BRAD SORENSON PHONE NO : 763-559-8492
14755 27TH AVE.NORTH SE DECISION MADE: 11-JUN-03
PLYMOUTH, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PRESSURE WIRE SENSOR, MODELS 12004/12304
RADI MEDICAL SYSTEMS AB 510(k) NO: K031662(SPECIAL)
ATTN: MATS GRANLUND PHONE NO : 46 18 161000
PALMBLADSGATAN 10 SE DECISION MADE: 06-JUN-03
UPPSALA, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKINSTATION
RADIANCY (ISRAEL) LTD. 510(k) NO: K030897(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 19-JUN-03
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO REMSTAR AUTO CPAP SYSTEM
RESPIRONICS, INC. 510(k) NO: K031460(SPECIAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 24-JUN-03
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE TEMPORARY PACING WIRE
RIVER MEDICAL, INC. 510(k) NO: K023174(TRADITIONAL)
ATTN: MARY ANN GREENAWALT PHONE NO : 503-230-1280
836 NE 24TH AVE. SE DECISION MADE: 11-JUN-03
PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY
ROCHE DIAGNOSTICS CORP. 510(k) NO: K031756(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 25-JUN-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
RUSCH INTL. 510(k) NO: K023666(TRADITIONAL)
ATTN: RICK LYKINS PHONE NO : 603-532-0204
50 PLANTATION DR. SE DECISION MADE: 17-JUN-03
JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYS
RUSCH INTL. 510(k) NO: K030559(TRADITIONAL)
ATTN: KARENANN J BROZOWSKI PHONE NO : 603-532-0204
50 PLANTATION DR. SE DECISION MADE: 30-JUN-03
JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERFERENTIAL STIMULATOR, MODEL NETWAVE
RYAN TELEMEDICINE 510(k) NO: K031884(TRADITIONAL)
ATTN: JIM KLETT PHONE NO : 800-495-7926
1011 BRIOSO DR., SUITE 102 SE DECISION MADE: 30-JUN-03
COSTA MESA, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY
SALIMETRICS LLC. 510(k) NO: K031348(SPECIAL)
ATTN: EVE SCHWARTZ PHONE NO : 814-234-7748
101 INNOVATION BLVD. SE DECISION MADE: 10-JUN-03
SUITE 302 510(k) SUMMARY AVAILABLE FROM FDA
STATE COLLEGE, PA 16803-6605
DEVICE: COOL CURE
SAMM, INC. 510(k) NO: K030811(TRADITIONAL)
ATTN: W. EDWARD JOHANSEN PHONE NO : 310-826-4902
11661 SAN VICENTE BLVD. SE DECISION MADE: 10-JUN-03
LOS ANGELES, CA 90049 510(k) STATEMENT
DEVICE: MIRACLE 98
SB LUCIUS, INC. 510(k) NO: K031010(TRADITIONAL)
ATTN: DAE-KYU CHANG PHONE NO : 714-530-2814
9778 KATELLA AVE. STE. 205 SE DECISION MADE: 25-JUN-03
ANAHEIM, CA 92804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGLIFE C/MAGLIFE C PLUS
SCHILLER MEDICAL S.A. 510(k) NO: K023195(ABBREVIATED)
ATTN: COURT GOEHRY PHONE NO : 333 886 33600
4 RUE LOUIS PASTEUR SE DECISION MADE: 03-JUN-03
ZAE SUD BP 90050 510(k) SUMMARY AVAILABLE FROM FDA
WISSEMBOURG CEDEX, FRANCE 67162
DEVICE: PROFILE 1064 LASER SYSTEM
SCITON, INC. 510(k) NO: K023881(TRADITIONAL)
ATTN: JAY M PATEL PHONE NO : 650-493-9155
845 COMMERCIAL ST. SE DECISION MADE: 13-JUN-03
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE POWDERED GREEN COLORED POWDERED LATEX PATIENT EXAMIN
SGMP CO., LTD. 510(k) NO: K030993(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 12-JUN-03
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GL
SGMP CO., LTD. 510(k) NO: K030994(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 12-JUN-03
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHANCHUAN SYRINGE
SHANGDONG ZIBO SHANCHUAN MEDICAL I510(k) NO: K021993(TRADITIONAL)
ATTN: HAIRONG CHE PHONE NO : 281-635-7686
12951 BRIAR FOREST DRIVE # 303 SE DECISION MADE: 03-JUN-03
HOUSTON, TX 77077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHELHIGH BIORING
SHELHIGH, INC. 510(k) NO: K023940(TRADITIONAL)
ATTN: SHLOMO GABBAY PHONE NO : 908-206-7806
650 LIBERTY AVE. SE DECISION MADE: 04-JUN-03
UNION, NJ 07083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS MICRO2+ WITH VAI SOFTWARE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K030640(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 03-JUN-03
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K030738(TRADITIONAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 06-JUN-03
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X
SINTEA BIOTECH, INC. 510(k) NO: K031154(TRADITIONAL)
ATTN: MARIANNE GRUNWALDT PHONE NO : 305-673-6226
407 LINCOLN RD. SUITE 10L SE DECISION MADE: 24-JUN-03
MIAMI BEACH, FL 33139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMISSON STABILIZATION SYSTEM
SMISSON-CARTLEDGE 510(k) NO: K021979(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 27-JUN-03
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY
SMITH & NEPHEW, INC. 510(k) NO: K031605(SPECIAL)
ATTN: JANICE HASELTON PHONE NO : 978-749-1494
150 MINUTEMAN RD. SE DECISION MADE: 18-JUN-03
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR
SMITH & NEPHEW, INC. 510(k) NO: K031675(SPECIAL)
ATTN: KAREN PROVENCHER PHONE NO : 978-749-1365
150 MINUTEMAN RD. SE DECISION MADE: 20-JUN-03
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTAC
SOFLEX CONTACT LENS INDUSTRIES LTD510(k) NO: K030842(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LN. SE DECISION MADE: 06-JUN-03
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: MERDOC SYSTEM
STRYKER ENDOSCOPY 510(k) NO: K022393(TRADITIONAL)
ATTN: KIRAN JAVADEKAR PHONE NO : 408-754-2241
5900 OPTICAL CT. SE DECISION MADE: 05-JUN-03
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER NAVIGATION SYSTEM-KNEE MODULE
STRYKER LEIBINGER 510(k) NO: K022579(TRADITIONAL)
ATTN: KELLI J BITTERBURG PHONE NO : 877-534-2464
4100 EAST MILHAM AVE. SE DECISION MADE: 02-JUN-03
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK
SURGISTAR, INC. 510(k) NO: K030891(TRADITIONAL)
ATTN: JONATHAN WOODWARD PHONE NO : 760-431-7400
6068 CORTE DEL CEDRO SE DECISION MADE: 17-JUN-03
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE S
SWISS ORTHOPEDIC SOLUTIONS INC 510(k) NO: K031609(TRADITIONAL)
ATTN: BOB BENNETT PHONE NO : 610-524-8142
26 TURNSTONE WAY SE DECISION MADE: 09-JUN-03
DOWNINGTON, PA 19335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE
SYNTHES (USA) 510(k) NO: K031573(TRADITIONAL)
ATTN: BONNIE J SMITH PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 06-JUN-03
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM
SYNTHES (USA) 510(k) NO: K031725(TRADITIONAL)
ATTN: BONNIE SMITH PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 24-JUN-03
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5
SYRINGEX MEDICAL, INC. 510(k) NO: K031065(TRADITIONAL)
ATTN: JOHN JONES PHONE NO : 801-553-2150
2311 BEAR HILLS COURT SE DECISION MADE: 23-JUN-03
DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOMEND
TEI BIOSCIENCES INC. 510(k) NO: K031188(ABBREVIATED)
ATTN: KENNETH JAMES PHONE NO : 617-268-1616
7 ELKINS ST. SE DECISION MADE: 27-JUN-03
BOSTON, MA 02127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER
THE KENDALL COMPANY DIV. OF TYCO H510(k) NO: K024010(TRADITIONAL)
ATTN: DAVID A OLSON PHONE NO : 508-261-8530
15 HAMPSHIRE ST. SE DECISION MADE: 11-JUN-03
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US
TYCO HEALTHCARE NANCY 510(k) NO: K031470(SPECIAL)
ATTN: JAMES BONDS PHONE NO : 925-463-4371
NELLCOR PURITAN BENNETT DIV. SE DECISION MADE: 05-JUN-03
4280 HACIENDA DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANTON, CA 94588
DEVICE: U&I, OPTIMA, SPINAL SYSTEM
U&I CORP., AMERICA 510(k) NO: K031585(SPECIAL)
ATTN: PATRICK MOORE PHONE NO : 801-262-3100
6132 SOUTH 380 WEST, SE DECISION MADE: 27-JUN-03
MURRAY, UT 84107-6988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U & I AMERICA SPINAL HOOK SYSTEM
U&I CORP., AMERICA 510(k) NO: K031595(TRADITIONAL)
ATTN: PATRICK MOORE PHONE NO : 801-262-3100
6132 SOUTH 380 WEST, SUITE 200 SE DECISION MADE: 24-JUN-03
MURRAY, UT 84107-6988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UF BRACHYTHERAPY STAND
UNIVERSITY OF FLORIDA 510(k) NO: K023430(TRADITIONAL)
ATTN: PATSY J TRISLER PHONE NO : 301-652-5344
5610 WISCONSIN AVENUE #304 SE DECISION MADE: 24-JUN-03
CHEVY CHASE, MD 20815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECLIPSE
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K030981(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 24-JUN-03
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
VASCULAR SOLUTIONS, INC. 510(k) NO: K030654(TRADITIONAL)
ATTN: DEBORAH JENSEN PHONE NO : 763-656-4349
2495 XENIUM LN. NORTH SE DECISION MADE: 18-JUN-03
MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBRYOGLUE
VITROLIFE SWEDEN AB 510(k) NO: K031015(TRADITIONAL)
ATTN: NINA ARVIDSSON PHONE NO : 463 172 180000
MOLNDALSVAGEN 30 SE DECISION MADE: 23-JUN-03
GOTHENBURG, SWEDEN SE-412 63 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVATHERM THEMPERATURE MEASUREMENT SYSTEM
VIVANT MEDICAL, INC. 510(k) NO: K031556(TRADITIONAL)
ATTN: STEVEN KIM PHONE NO : 650-694-2900
1916-A OLD MIDDLEFIELD WAY SE DECISION MADE: 23-JUN-03
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FINAL VARNISH LC
VOCO GMBH 510(k) NO: K030844(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 13-JUN-03
BEND, OR 97702 510(k) STATEMENT
DEVICE: WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET
WAKO CHEMICALS, USA, INC. 510(k) NO: K024280(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 804-271-7677
1600 BELLWOOD RD. SE DECISION MADE: 06-JUN-03
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LORENZE EXTERNAL MANDIBULAR DISTRACTOR
WALTER LORENZ SURGICAL, INC. 510(k) NO: K031696(SPECIAL)
ATTN: KIM REED PHONE NO : 904-741-9443
1520 TRADEPORT DR. SE DECISION MADE: 17-JUN-03
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPIDFIRE SELF DRILLING SCREWS
WALTER LORENZ SURGICAL, INC. 510(k) NO: K031751(SPECIAL)
ATTN: KIM REED PHONE NO : 904-741-4400
1520 TRADEPORT DR. SE DECISION MADE: 26-JUN-03
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WARTNER PRO
WARTNER MEDICAL PRODUCTS 510(k) NO: K030838(TRADITIONAL)
ATTN: NANCY LUM-WILSON PHONE NO : 905 884 7855
65 AVA CRESCENT SE DECISION MADE: 27-JUN-03
RICHMOND HILL, ONTARIO, CANADA L4B510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTA PRESSOVER
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K031264(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 497 231 3705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 12-JUN-03
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGINE REFLEX
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K031326(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRASSE 13 SE DECISION MADE: 17-JUN-03
PFORZHEIM, GERMANY D75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP
WINNER INDUSTRIES (SHENZHEN) CO., 510(k) NO: K023755(TRADITIONAL)
ATTN: MING XIE PHONE NO : 949-261-5339
17815 SKY PARK CIRCLE SE DECISION MADE: 10-JUN-03
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
IRVINE, CA 92614
DEVICE: HI-FLO THERME PNEU 45, WISAP #7083, 7083V
WISAP GESELLSCHAFT FUR WISSENSCHAF510(k) NO: K031014(TRADITIONAL)
ATTN: HORST SEMM PHONE NO : 490 810 489080
RUDOLF-DIESEL-RING 20 SE DECISION MADE: 27-JUN-03
SAUERLACH, GERMANY D-82054 510(k) STATEMENT
DEVICE: READI-STRAND, MODEL PSSTRAND
WORLDWIDE MEDICAL TECHNOLOGIES, IN510(k) NO: K022705(TRADITIONAL)
ATTN: GARY LAMOUREUX PHONE NO : 203-263-2579
426 MAIN ST. NORTH SE DECISION MADE: 09-JUN-03
P.O. BOX 505 510(k) STATEMENT
WOODBURY, CT 06798-0505
DEVICE: YA MEI FIRST AID KIT
YA MEI TECHNOLOGY CO., LTD. 510(k) NO: K031130(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LN. SE DECISION MADE: 27-JUN-03
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE
YTY INDUSTRY (MANJUNG) SDN. BHD. 510(k) NO: K031384(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 17-JUN-03
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM
ZIMMER, INC. 510(k) NO: K030724(TRADITIONAL)
ATTN: KAREN CAIN PHONE NO : 574-372-4219
P.O. BOX 708 SE DECISION MADE: 03-JUN-03
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923
ZIMMER, INC. 510(k) NO: K031572(SPECIAL)
ATTN: KAREN CAIN PHONE NO : 574-372-4219
P.O. BOX 708 SE DECISION MADE: 24-JUN-03
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPID IMF
ZYGOMATICS LTD. 510(k) NO: K030605(TRADITIONAL)
ATTN: CAROL MACDONALD PHONE NO : 440 780 1655887
20A MONTPELIER VALE SE DECISION MADE: 27-JUN-03
LONDON SE3 0TA, UNITED KINGDOM 510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 265
TOTAL WITH SUMMARIES 220
TOTAL WITH STATEMENTS 45
Updated 7/8/2003
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