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Medical Devices
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January 2003 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-JAN-2003 THROUGH 31-JAN-2003
DEVICE: PICCOLO TRIGLYCERIDES TEST SYSTEM
ABAXIS, INC. 510(k) NO: K023639(TRADITIONAL)
ATTN: DENNIS M BLEILE PHONE NO : 510-675-6515
3240 WHIPPLE RD. SE DECISION MADE: 24-JAN-03
UNION CITY, CA 94587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICCOLO HDL TEST SYSTEM
ABAXIS, INC. 510(k) NO: K023640(TRADITIONAL)
ATTN: DENNIS M BLEILE PHONE NO : 510-675-6515
3240 WHIPPLE RD. SE DECISION MADE: 24-JAN-03
UNION CITY, CA 94587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICCOLO TOTAL CHOLESTEROL TEST SYSTEM
ABAXIS, INC. 510(k) NO: K023642(TRADITIONAL)
ATTN: DENNIS M BLEILE PHONE NO : 510-675-6515
3240 WHIPPLE RD. SE DECISION MADE: 24-JAN-03
UNION CITY, CA 94587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RHEUMATOID FACTOR (RF)
ABBOTT LABORATORIES 510(k) NO: K024067(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711
1920 HURD DRIVE SE DECISION MADE: 15-JAN-03
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATO
ABBOTT LABORATORIES 510(k) NO: K024126(SPECIAL)
ATTN: NICOHL R WILDING PHONE NO : 847-935-6557
200 ABBOTT PARK ROAD SE DECISION MADE: 14-JAN-03
D-389, BLDG J-45 510(k) STATEMENT
ABBOTT PARK, IL 60064-3500
DEVICE: CHEMO DISPENSING PIN, MODEL 12495
ABBOTT LABORATORIES 510(k) NO: K024239(SPECIAL)
ATTN: NICOHL R WILDING PHONE NO : 847-935-6557
DEPT 0389 BLDG J-45 SE DECISION MADE: 13-JAN-03
200 ABBOTT PARK ROAD 510(k) STATEMENT
ABBOTT PARK, IL 60064-6133
DEVICE: LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-D
ABBOTT LABORATORIES 510(k) NO: K030002(SPECIAL)
ATTN: NOCOHL R WILDING PHONE NO : 847-935-6557
D-389, BLDG. J-45 SE DECISION MADE: 27-JAN-03
200 ABBOTT PARK ROAD 510(k) STATEMENT
ABBOTT PARK, IL 60064-6133
DEVICE: PENTRA 80
ABX DIAGNOSTICS 510(k) NO: K024002(SPECIAL)
ATTN: TIM LAWTON PHONE NO : 33 467 147320
PARC EUROMEDECINE SE DECISION MADE: 03-JAN-03
RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA
MONPELLIER, FRANCE 34184
DEVICE: MODIFICATION TO PENTRA 60 AND PENTRA 60C+
ABX DIAGNOSTICS 510(k) NO: K030144(SPECIAL)
ATTN: TIM LAWTON PHONE NO : 33 467 147320
PARC EUROMEDECINE SE DECISION MADE: 31-JAN-03
RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA
MONPELLIER, FRANCE 34184
DEVICE: SOFT TISSUE ANCHORING WASHERS
ACCU-SPEED, INCORPORATED 510(k) NO: K030031(TRADITIONAL)
ATTN: ROBERT W SECOVICH PHONE NO : 978-448-0997
P.O. BOX 1008, 65 GAY ROAD SE DECISION MADE: 28-JAN-03
GROTON, MA 01450 510(k) STATEMENT
DEVICE: ACIST GENTOO CONTRAST INJECTION SYSTEM
ACIST MEDICAL SYSTEMS 510(k) NO: K020892(ABBREVIATED)
ATTN: CARL M BEAURLINE PHONE NO : 952-995-9319
7450 FLYING CLOUDS DR. SE DECISION MADE: 27-JAN-03
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
EDEN PRAIRIE, MN 55344
DEVICE: USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8
ACMI CORPORATION 510(k) NO: K023358(TRADITIONAL)
ATTN: TERRENCE SULLIVAN PHONE NO : 508-804-2739
136 TURNPIKE ROAD SE DECISION MADE: 03-JAN-03
SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST
ADVANCE DIAGNOSTICS 510(k) NO: K023712(TRADITIONAL)
ATTN: JANIS FREESTONE PHONE NO : 408-745-7455
764 SAN ALESO AVE. SE DECISION MADE: 31-JAN-03
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AHL GENERIC GLASS IONOMER LUTING CEMENT
ADVANCED HEALTHCARE LTD. 510(k) NO: K023981(TRADITIONAL)
ATTN: BILL ETTINGER PHONE NO : 813-831-6161
2907 BAY TO BAY BLVD SE DECISION MADE: 31-JAN-03
# 214 510(k) STATEMENT
TAMPA, FL 33629
DEVICE: AMI REPROCESSED FEMORAL COMPRESSION DEVICE
ADVEN MEDICAL 510(k) NO: K012692(TRADITIONAL)
ATTN: MARK W ALDANA PHONE NO : 806-745-7718
1001 SLATON HWY. SE DECISION MADE: 24-JAN-03
LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMISIL SCAR GEL
AESTHETIC AND RECONSTRUCTIVE TECHN510(k) NO: K023678(TRADITIONAL)
ATTN: CATHERINE RIPLE PHONE NO : 805-239-1059
5871 LONE PINE PLACE SE DECISION MADE: 23-JAN-03
PASO ROBLES, CA 93446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TEMNO BIOPSY NEEDLES
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K024120(SPECIAL)
ATTN: SHARON NICHOLS PHONE NO : 847-785-3311
1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 15-JAN-03
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLO
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K024292(SPECIAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 09-JAN-03
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036
ALPHATEK CORP. 510(k) NO: K023613(TRADITIONAL)
ATTN: PAUL M KUPSCO PHONE NO : 708-345-0500
2000 SOUTH 25TH AVE. SE DECISION MADE: 23-JAN-03
BROADVIEW, IL 60153 510(k) STATEMENT
DEVICE: RDH-2000
ANODIA SYSTEMS 510(k) NO: K023213(TRADITIONAL)
ATTN: THAD OVERMYER PHONE NO : 866-246-2548
514 SOUTH THIRD STREET SE DECISION MADE: 16-JAN-03
DANVILLE, KY 40422 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURESET 3.0 ML RESERVOIR, MODEL 24-103
APPLIED DIABETES RESEARCH, INCORPO510(k) NO: K024056(TRADITIONAL)
ATTN: JAMES BARLEY PHONE NO : 949-433-3058
28481 LAFALDA SE DECISION MADE: 17-JAN-03
LAGUNA NIGUEL, CA 92677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILVERLON ADHESIVE STRIP
ARGENTUM INTERNATIONAL LLC. 510(k) NO: K023609(TRADITIONAL)
ATTN: BART FLICK PHONE NO : 706-782-6700
PO BOX 429 SE DECISION MADE: 17-JAN-03
LAKEMONT, GA 30552 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILVERLON CONTACT WOUND DRESSING
ARGENTUM INTERNATIONAL LLC. 510(k) NO: K023612(TRADITIONAL)
ATTN: BART FLICK PHONE NO : 706-782-6700
PO BOX 429 SE DECISION MADE: 24-JAN-03
LAKEMONT, GA 30552 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "LFRE" INDIRECT LARYNGOSCOPE
ASTRALITE CORP. 510(k) NO: K023004(TRADITIONAL)
ATTN: DORIAN SWARTZ PHONE NO : 818-398-7055
7701 WOODLEY AVE. SE DECISION MADE: 28-JAN-03
VAN NUYS, CA 91406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AURORA MR-GUIDED INTERVENTIONAL SYSTEM
AURORA IMAGING TECHNOLOGY, INC. 510(k) NO: K023686(TRADITIONAL)
ATTN: ALAN OSLAN PHONE NO : 978-975-7530
39 HIGH STREET SE DECISION MADE: 29-JAN-03
NORTH ANDOVER, MA 01845 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXONE IV FLUID/BLOOD WARMER, MODEL 102
AUTOMATIC MEDICAL TECHNOLOGIES, IN 510(k) NO: K023653(TRADITIONAL)
ATTN: CINDY MARTIN PHONE NO : 714-543-1168
1711 NORTH BUSH STREET SE DECISION MADE: 17-JAN-03
SANTA ANA, CA 92706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPID THERMAL EXCHANGE SYSTEM
AVACORE TECHNOLOGIES, INC. 510(k) NO: K023934(TRADITIONAL)
ATTN: CRAIG COOMBS PHONE NO : 415-531-1932
251 HIGH STREET, SUITE B SE DECISION MADE: 23-JAN-03
PALO ALTO, CA 94301 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AVANT GUARDIAN 101
AVANT MEDICAL CORPORATION 510(k) NO: K024018(TRADITIONAL)
ATTN: JOHN B SLATE PHONE NO : 858-273-3674
3914 KENDALL STREET SE DECISION MADE: 17-JAN-03
SAN DIEGO, CA 92109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRX3000
AXIOM USA. INC 510(k) NO: K022602(TRADITIONAL)
ATTN: JIM GIBSON PHONE NO : 813-969-2414
3830 GUNN HWY SE DECISION MADE: 23-JAN-03
TAMPA, FL 33624 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASOUND SCANNER, TYPE 2400
B-K MEDICAL A/S 510(k) NO: K024236(SPECIAL)
ATTN: VILLY BRAENDER PHONE NO : 011 454 4528100
MILEPARKEN 34 SE DECISION MADE: 17-JAN-03
HERLEV, DENMARK DK-2730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARCO MEDIS 5MP2 AURA
BARCO NV 510(k) NO: K023533(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
P.O. BOX 12038 SE DECISION MADE: 17-JAN-03
LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER ADVIA CENTAUR HER-2/NEU ASSAY
BAYER CORP. 510(k) NO: K024017(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE. SE DECISION MADE: 30-JAN-03
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL
BAYER CORP. 510(k) NO: K024234(TRADITIONAL)
ATTN: GEORGE M TANCOS PHONE NO : 219-262-6928
1884 MILES AVE. SE DECISION MADE: 23-JAN-03
P.O. BOX 70 510(k) SUMMARY AVAILABLE FROM FDA
ELKHART, IN 46514-0070
DEVICE: ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650
BAYER DIAGNOSTICS CORP. 510(k) NO: K023840(TRADITIONAL)
ATTN: ANDRES HOLLE PHONE NO : 914-524-3494
511 BENEDICT AVE SE DECISION MADE: 07-JAN-03
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
BAYER HEALTHCARE, LLC 510(k) NO: K030102(ABBREVIATED)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVENUE SE DECISION MADE: 24-JAN-03
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SETPOINT CHEMISTRY CALIBRATOR
BAYER HEALTHCARE, LLC 510(k) NO: K030169(ABBREVIATED)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVENUE SE DECISION MADE: 31-JAN-03
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
BECKMAN COULTER, INC. 510(k) NO: K023764(TRADITIONAL)
ATTN: LYNN WEIST PHONE NO : 952-368-1271
1000 LAKE HAZELTINE DR. SE DECISION MADE: 28-JAN-03
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, M
BECKMAN COULTER, INC. 510(k) NO: K030012(SPECIAL)
ATTN: BRENT TABER PHONE NO : 952-368-1323
1000 LAKE HAZELTINE DRIVE SE DECISION MADE: 17-JAN-03
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD INSULIN SYRINGE
BECTON DICKINSON & CO. 510(k) NO: K024112(SPECIAL)
ATTN: JOHN A SCHALAGO PHONE NO : 201-847-5663
1 BECTON DRIVE SE DECISION MADE: 09-JAN-03
FRANKLIN LAKES, NJ 07417-1880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
BECTON, DICKINSON AND COMPANY 510(k) NO: K023568(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 24-JAN-03
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN
BECTON, DICKINSON AND COMPANY 510(k) NO: K023895(TRADITIONAL)
ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778
7 LOVETON CIR. SE DECISION MADE: 08-JAN-03
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/M
BECTON, DICKINSON AND COMPANY 510(k) NO: K024152(TRADITIONAL)
ATTN: KATHRYN BABKA POWERS PHONE NO : 410-316-4260
7 LOVETON CIR. SE DECISION MADE: 31-JAN-03
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND
BERKELEY ADVANCED BIOMATERIALS, IN510(k) NO: K022622(TRADITIONAL)
ATTN: FRANCOIS GENIN PHONE NO : 510-883-1644
1933 DAVIS ST. SUITE 307 SE DECISION MADE: 09-JAN-03
SAN LEANDRO, CA 94577 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BI-OSTETIC
BERKELEY ADVANCED BIOMATERIALS, IN510(k) NO: K023703(TRADITIONAL)
ATTN: FRANCOIS GENIN PHONE NO : 510-883-1644
1933 DAVIS ST. SUITE 307 SE DECISION MADE: 30-JAN-03
SAN LEANDRO, CA 94577 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BICON TRANSITIONAL IMPLANT (BTI) SYSTEM
BICON, INC. 510(k) NO: K023705(TRADITIONAL)
ATTN: VINCENT J MORGAN PHONE NO : 617-524-4443
501 ARBOWAY SE DECISION MADE: 29-JAN-03
BOSTON, MA 02130 510(k) STATEMENT
DEVICE: LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108
BIO-RAD 510(k) NO: K024217(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 15-JAN-03
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114
BIO-RAD 510(k) NO: K024218(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 17-JAN-03
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115
BIO-RAD 510(k) NO: K024219(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 15-JAN-03
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130
BIO-RAD 510(k) NO: K024220(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 949-598-1465
9500 JERONIMO RD. SE DECISION MADE: 17-JAN-03
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CAT
BIO-RAD 510(k) NO: K024221(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 15-JAN-03
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112
BIO-RAD 510(k) NO: K024222(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 15-JAN-03
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116
BIO-RAD 510(k) NO: K024223(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 13-JAN-03
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129
BIO-RAD 510(k) NO: K024224(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 15-JAN-03
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119
BIO-RAD 510(k) NO: K024225(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 15-JAN-03
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116
BIO-RAD 510(k) NO: K024226(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 10-JAN-03
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127
BIO-RAD 510(k) NO: K024227(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 15-JAN-03
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111
BIO-RAD 510(k) NO: K024229(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 15-JAN-03
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENT
BIO-RAD 510(k) NO: K024230(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 15-JAN-03
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALO
BIO-RAD 510(k) NO: K024231(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 13-JAN-03
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113
BIO-RAD 510(k) NO: K024232(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 17-JAN-03
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GOOD LUBRICATIONS
BIOFILM, INC. 510(k) NO: K020586(TRADITIONAL)
ATTN: ROBERT L DE ARMOND PHONE NO : 760-727-9030
3121 SCOTT ST. SE DECISION MADE: 24-JAN-03
VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODE
BIOLITEC, INC. 510(k) NO: K024088(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST., NW SE DECISION MADE: 02-JAN-03
WASHINGTON, DC 20004-5910 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
BIOMET ORTHOPEDICS, INC. 510(k) NO: K024086(SPECIAL)
ATTN: KACY ARNOLD PHONE NO : 574-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 09-JAN-03
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: DHS DISPOSABLE HOOD SYSTEM
BIOMET, INC. 510(k) NO: K021992(TRADITIONAL)
ATTN: KACY ARNOLD PHONE NO : 574-372-1644
P.O. BOX 587 SE DECISION MADE: 14-JAN-03
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXIM ACCEL KNEE SYSTEM
BIOMET, INC. 510(k) NO: K023546(TRADITIONAL)
ATTN: TRACY J BICKEL PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 17-JAN-03
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEO-CABLE SLEEVE
BIOMET, INC. 510(k) NO: K024022(SPECIAL)
ATTN: KACY ARNOLD PHONE NO : 574-372-1644
56 EAST BELL DR. SE DECISION MADE: 23-JAN-03
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREEDOM CONSTRAINED LINERS
BIOMET, INC. 510(k) NO: K030047(SPECIAL)
ATTN: MAX T HEBEL PHONE NO : 219-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 23-JAN-03
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46582
DEVICE: CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM
BIOSENSE WEBSTER, INC. 510(k) NO: K020863(SPECIAL)
ATTN: WILLIAM WELCH PHONE NO : 800-729-9010
3333 DIAMOND CANYON RD. SE DECISION MADE: 09-JAN-03
DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO
BIOSITE INCORPORATED 510(k) NO: K030088(TRADITIONAL)
ATTN: JEFFREY R DAHLEN PHONE NO : 858-455-4808
11030 ROSELLE ST. SE DECISION MADE: 17-JAN-03
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS
BIOSITE INCORPORATED 510(k) NO: K030089(TRADITIONAL)
ATTN: JEFFREY R DAHLEN PHONE NO : 858-455-4808
11030 ROSELLE ST. SE DECISION MADE: 23-JAN-03
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 30
BIOTRONIK, INC. 510(k) NO: K022360(TRADITIONAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN RD. SE DECISION MADE: 27-JAN-03
LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUAL-LUMEN CATHETER
BISTECH, INC. 510(k) NO: K024165(ABBREVIATED)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 10-JAN-03
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONART ART-L2 LIGHT CURING UNIT
BONART CO. LTD. 510(k) NO: K023721(TRADITIONAL)
ATTN: ERIC L ONG PHONE NO : 909-594-8066
398 S. LEMON CREEK DRIVE SE DECISION MADE: 10-JAN-03
STE. L 510(k) STATEMENT
WALNUT, CA 91789
DEVICE: VAXCEL WITH PASV PORT
BOSTON SCIENTIFIC CORP. 510(k) NO: K030083(SPECIAL)
ATTN: JODI LYNN GREENIZEN PHONE NO : 518-742-4338
10 GLENS FALLS TECHNICAL PARK SE DECISION MADE: 28-JAN-03
GLENS FALLS, NY 12801-3864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED
BOSTON SCIENTIFIC SCIMED, INC. 510(k) NO: K024048(SPECIAL)
ATTN: TODD KORNMANN PHONE NO : 800-553-5878
ONE SCIMED PLACE SE DECISION MADE: 06-JAN-03
MAPLE GROVE, MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM
C.R. BARD, INC. 510(k) NO: K021994(ABBREVIATED)
ATTN: AYMEE BERRY PHONE NO : 480-303-2752
1625 WEST 3RD STREET SE DECISION MADE: 02-JAN-03
TEMPE, AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD ER URETERAL STENT WITH SUTURE
C.R. BARD, INC. 510(k) NO: K022447(TRADITIONAL)
ATTN: DONNA J WILSON PHONE NO : 770-784-6135
8195 INDUSTRIAL BLVD. SE DECISION MADE: 23-JAN-03
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CANDELA SMOOTHBEAM LASER SYSTEM
CANDELA CORP. 510(k) NO: K022884(TRADITIONAL)
ATTN: LORAINE NELSON PHONE NO : 508-358-7637
530 BOSTON POST RD. SE DECISION MADE: 22-JAN-03
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG
CANDELA CORP. 510(k) NO: K022951(TRADITIONAL)
ATTN: LORRAINE NELSON PHONE NO : 508-358-7637
530 BOSTON POST RD. SE DECISION MADE: 27-JAN-03
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VER
CANOPUS MEDICAL SUPPLY CO., LTD. 510(k) NO: K023728(TRADITIONAL)
ATTN: RUBY LIN PHONE NO : 011 886 227162107
201 FU-HSING NORTH RD., 10TH SE DECISION MADE: 07-JAN-03
FL. 510(k) STATEMENT
TAIPEI, CHINA (TAIWAN) 105
DEVICE: KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K023356(TRADITIONAL)
ATTN: ALEX GONOROVSKY PHONE NO : 972 894 84600
2 PEKERIS STREET SE DECISION MADE: 16-JAN-03
REHOVOT, ISRAEL 510(k) STATEMENT
DEVICE: CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K023689(TRADITIONAL)
ATTN: ALEX GONOROVSKY PHONE NO : 972 8 9484600
2 PEKERIS ST. SE DECISION MADE: 17-JAN-03
PO BOX 527 510(k) STATEMENT
REHOVOT, ISRAEL 76100
DEVICE: TM2005 PERSONAL MEDICAL PHONE CENTER
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K024365(SPECIAL)
ATTN: ALEX GONOROVSKY PHONE NO : 972 894 84600
2 PERERIS ST., SCIENCE PARK SE DECISION MADE: 15-JAN-03
REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWE
CARDIAC SCIENCE, INC. 510(k) NO: K022929(TRADITIONAL)
ATTN: JOHN CARLINE PHONE NO : 952-939-4181
16931 MILLIKAN AVE. SE DECISION MADE: 27-JAN-03
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIMA ABLATION SYSTEM
CARDIMA, INC. 510(k) NO: K022008(TRADITIONAL)
ATTN: ROBERT A CHIN PHONE NO : 650-593-5225
25 HARTFORD AVENUE SE DECISION MADE: 29-JAN-03
SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
CARDIOMEDICS, INC. 510(k) NO: K023427(TRADITIONAL)
ATTN: GARY CLARK PHONE NO : 949-863-2500
18872 BARDEEN AVE. SE DECISION MADE: 07-JAN-03
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100
CARDIOVENTION, INC. 510(k) NO: K021694(TRADITIONAL)
ATTN: TESSA YAMUT PHONE NO : 408-844-5130
3045 STENDER WAY SE DECISION MADE: 08-JAN-03
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE
CENTERPLUS ORTHOPEDICS, INC 510(k) NO: K023528(TRADITIONAL)
ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9202
9900 SPECTRUM DRIVE SE DECISION MADE: 17-JAN-03
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CDS 3-PD HEMATOLOGY CONTROLS
CLINICAL DIAGNOSTIC SOLUTIONS, INC510(k) NO: K024173(TRADITIONAL)
ATTN: ANDREW C SWANSON PHONE NO : 954-791-7118
1660 N.W. 65TH AVE., SUITE 2 SE DECISION MADE: 14-JAN-03
PLANTATION, FL 33313 510(k) STATEMENT
DEVICE: COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS AN
CLINICAL INNOVATIONS, INC. 510(k) NO: K022023(TRADITIONAL)
ATTN: WILLIAM DEAN WALLACE PHONE NO : 801-268-8200
747 WEST 4170 SOUTH SE DECISION MADE: 07-JAN-03
MURRAY, UT 84123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN
CLINIQA CORPORATION 510(k) NO: K030074(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION ROAD SE DECISION MADE: 21-JAN-03
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN C
CLINIQA CORPORATION 510(k) NO: K030150(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432-B SOUTH MISSION RD. SE DECISION MADE: 28-JAN-03
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)
CLOVER HI-TECH INC. 510(k) NO: K022596(TRADITIONAL)
ATTN: CECILIA L YU PHONE NO : 626-964-6680
17800 CASTLETON STREET SE DECISION MADE: 31-JAN-03
SUITE 415 510(k) STATEMENT
CITY OF INDUSTRY, CA 91748
DEVICE: COALESCENT SURGICAL U-CLIP AND ACCESSORIES
COALESCENT SURGICAL 510(k) NO: K024366(SPECIAL)
ATTN: MICHAEL A DANIEL PHONE NO : 415-407-0223
559 EAST WEDDELL DR. SE DECISION MADE: 17-JAN-03
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPEEDICATH
COLOPLAST CORP. 510(k) NO: K023254(TRADITIONAL)
ATTN: ELIZABETH BOOTS PHONE NO : 507-386-4362
1940 COMMERCE DR. SE DECISION MADE: 27-JAN-03
NORTH MANKATO, MN 56003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPUMEDICS SOMTE SYSTEM
COMPUMEDICS LIMITED 510(k) NO: K021176(TRADITIONAL)
ATTN: CONSTANCE G BUNDY PHONE NO : 763-574-1976
6740 RIVERVIEW TERRACE SE DECISION MADE: 21-JAN-03
MINNEAPOLIS,, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
COMPUTER MOTION, INC. 510(k) NO: K024294(SPECIAL)
ATTN: CATHY STUPAK PHONE NO : 805-685-3729
130-B CREMONA DRIVE SE DECISION MADE: 08-JAN-03
SANTA BARBARA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHARP VIEW IMAGE ENHANCEMENT SYSTEM
CONTEXT VISION AB 510(k) NO: K024028(TRADITIONAL)
ATTN: KENT STRANDLUND PHONE NO : 460 133 58561
STORGATAN 24 SE DECISION MADE: 24-JAN-03
LINKOPING, SWEDEN SE-582 23 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYDNEY IVF EMBRYO BIOPSY MEDIUM
COOK OB/GYN 510(k) NO: K023850(TRADITIONAL)
ATTN: DEBBIE SCHMITT PHONE NO : 812-829-6500
1100 W. MORGAN STREET SE DECISION MADE: 22-JAN-03
SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOPERSURGICAL OOCYTE RECOVERY NEEDLES
COOPERSURGICAL, INC. 510(k) NO: K023930(TRADITIONAL)
ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320
P.O. BOX 2156 SE DECISION MADE: 22-JAN-03
HUNTINGTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATI
CORGENIX, INC. 510(k) NO: K024195(SPECIAL)
ATTN: NANCI DEXTER PHONE NO : 303-457-4345
12061 TEJON ST. SE DECISION MADE: 03-JAN-03
WESTMINSTER, CO 80234 510(k) STATEMENT
DEVICE: REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KI
CORGENIX, INC. 510(k) NO: K024196(SPECIAL)
ATTN: NANCI DEXTER PHONE NO : 303-457-4345
12061 TEJON ST. SE DECISION MADE: 03-JAN-03
WESTMINSTER, CO 80234 510(k) STATEMENT
DEVICE: COSMED MICROQUARK
COSMED S.R.L. 510(k) NO: K020745(TRADITIONAL)
ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830
1129 BLOOMFIELD AVENUE SE DECISION MADE: 02-JAN-03
WEST CALDWELL, NJ 07006 510(k) STATEMENT
DEVICE: VISORB SWIFT
CP MEDICAL 510(k) NO: K023710(TRADITIONAL)
ATTN: MARY ANN GREENAWALT PHONE NO : 503-232-1555
836 N.E. 24TH AVE. SE DECISION MADE: 17-JAN-03
PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA
CREATIVE TECHNOLOGIES, INC. 510(k) NO: K022807(TRADITIONAL)
ATTN: ELIZABETH P NOBLE PHONE NO : 704-640-5547
423 BETHEL DRIVE SE DECISION MADE: 29-JAN-03
SALISBURY, NC 28144 510(k) STATEMENT
DEVICE: STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDM
DADE BEHRING, INC. 510(k) NO: K022976(TRADITIONAL)
ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567
GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 16-JAN-03
BLDG 500, MS 514 P.O.BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: MODIFICATION TO STANDARD HUMAN PLASMA
DADE BEHRING, INC. 510(k) NO: K023141(TRADITIONAL)
ATTN: DONNA A WOLF PHONE NO : 302-631-0384
514 GBC DRIVE SE DECISION MADE: 16-JAN-03
NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES
DATEX-OHMEDA 510(k) NO: K023459(TRADITIONAL)
ATTN: JOEL KENT PHONE NO : 781 449 8685
86 PILGRIM ROAD SE DECISION MADE: 13-JAN-03
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS
DELTEC, INC. 510(k) NO: K022221(TRADITIONAL)
ATTN: LISA STONE PHONE NO : 651-628-7224
1265 GREY FOX RD. SE DECISION MADE: 30-JAN-03
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XENO III DENTAL ADHESIVE
DENTSPLY INTL. 510(k) NO: K023776(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE SE DECISION MADE: 23-JAN-03
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOSS MIAMI SPINAL SYSTEM PIN NUT
DEPUY ACROMED 510(k) NO: K023804(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 23-JAN-03
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEVEX MESH SYSTEM
DEPUY ACROMED 510(k) NO: K023835(SPECIAL)
ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704
325 PARAMOUNT DR. SE DECISION MADE: 29-JAN-03
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONARCH SPINE SYSTEM
DEPUY ACROMED 510(k) NO: K024348(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 28-JAN-03
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOSE-SL-C ASSAY, MODEL 257-30
DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K023739(TRADITIONAL)
ATTN: NANCY OLSCAMP PHONE NO : 902 566 1396
16 MCCARVILLE ST SE DECISION MADE: 17-JAN-03
CHARLOTTETOWN, PE, CANADA C1E2A6 510(k) STATEMENT
DEVICE: ACCULEAF
DIREX SYSTEMS CORP. 510(k) NO: K021338(TRADITIONAL)
ATTN: LARISA GERSHTEIN PHONE NO : 888-874-7837
11 MERCER ROAD SE DECISION MADE: 07-JAN-03
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIPTER X-1 COMPACT DUET
DIREX SYSTEMS CORP. 510(k) NO: K023535(SPECIAL)
ATTN: LARISA GERSHTEIN PHONE NO : 508-651-0900
11 MERCER ROAD SE DECISION MADE: 17-JAN-03
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLASH-LITE II LED DENTAL CURING LIGHT
DISCUS DENTAL, INC. 510(k) NO: K023748(TRADITIONAL)
ATTN: GARY L HOLLAR PHONE NO : 310-845-8345
8550 HIGUERA STREET SE DECISION MADE: 17-JAN-03
CULVER CITY, CA 90232 510(k) STATEMENT
DEVICE: VITIQUE SYSTEM
DMG USA, INC. 510(k) NO: K023649(ABBREVIATED)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 17-JAN-03
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072
DRAGER MEDIZINTECHNIK GMBH 510(k) NO: K023289(SPECIAL)
ATTN: JAMES J BRENNAN PHONE NO : 215-721-5400
3136 QUARRY ROAD SE DECISION MADE: 15-JAN-03
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EBI XFIX DFS SYSTEM
EBI, L.P. 510(k) NO: K024129(SPECIAL)
ATTN: JON CAPAROTTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 15-JAN-03
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTE
EBI, L.P. 510(k) NO: K024248(SPECIAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 22-JAN-03
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MUCOGRAFT
ED. GEISTLICH SOEHNE AG FUER CHEMI510(k) NO: K012423(TRADITIONAL)
ATTN: PETER S REICHERTZ PHONE NO : 202-857-6378
1050 CONNECTICUT AVE. NW SE DECISION MADE: 24-JAN-03
WASHINGTON, DC 20036 510(k) STATEMENT
DEVICE: UNISIGHT SYSTEM WITH UNIGATE
ELECTRONIC BUSINESS MACHINE CO., L510(k) NO: K023394(ABBREVIATED)
ATTN: DAVID LIN PHONE NO : 808-945-3100
1600 KAPIDLANI BLVD SE DECISION MADE: 07-JAN-03
SUITE 1224 510(k) STATEMENT
HONOLULU, HI 96814
DEVICE: MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5
ELLTEC CO., LTD. 510(k) NO: K024373(SPECIAL)
ATTN: RIEKO SO PHONE NO : 81 52 2017308
SHIRAKAWA NO. 6 BLDG. 2-18-5 SE DECISION MADE: 28-JAN-03
NISHIKI, NAKA-KU 510(k) STATEMENT
NAGOYA, JAPAN
DEVICE: EPW POWERED WHEELCHAIR, GP-201
EMG TECHNOLOGY CO., LTD. 510(k) NO: K023148(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHINU ST. SE DECISION MADE: 24-JAN-03
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERBE VIO APC WITH ACCESSORIES
ERBE USA, INC. 510(k) NO: K024047(SPECIAL)
ATTN: JULIE STEPHENS PHONE NO : 770-923-7219
550 BELGRAVE LANE SE DECISION MADE: 08-JAN-03
TUCKER, GA 30084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITREX NITINOL GUIDEWIRE
EV3 CORPORATION 510(k) NO: K024021(SPECIAL)
ATTN: PHIL NEURURER PHONE NO : 763-398-7094
4600 NATHAN LANE SE DECISION MADE: 24-JAN-03
PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXEL SECURETOUCH PTP SYRINGE
EXELINT INTL. CO. 510(k) NO: K011754(TRADITIONAL)
ATTN: ARMAND HAMID PHONE NO : 310-649-0707
P.O. BOX 3194 SE DECISION MADE: 22-JAN-03
CULVER CITY, CA 90231-3194 510(k) STATEMENT
DEVICE: AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
EXTERNAL COUNTERPULSATION LAB 510(k) NO: K021340(TRADITIONAL)
ATTN: DAWEI CAI PHONE NO : 216-324-0100
85 WU JIN ROAD SE DECISION MADE: 30-JAN-03
SHANGHAI, CHINA 200080 510(k) STATEMENT
DEVICE: LESSER METATARSAL PHALANGEAL JOINT IMPLANT
FUTURA BIOMEDICAL 510(k) NO: K023531(TRADITIONAL)
ATTN: LOUISE M FOCHT PHONE NO : 760-599-1670
990 PARK CENTER DR., SUITE H SE DECISION MADE: 17-JAN-03
VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPORARY CEMENT-DC010002
GC AMERICA, INC. 510(k) NO: K023727(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-597-0900
3737 WEST 127TH ST. SE DECISION MADE: 16-JAN-03
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: EXAJET
GC AMERICA, INC. 510(k) NO: K023751(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 22-JAN-03
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: GRADIA DIRECT
GC AMERICA, INC. 510(k) NO: K023814(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 30-JAN-03
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: JUPITER PROCESSING AND REVIEW WORKSTATION
GE MEDICAL SYSTEMS, INC. 510(k) NO: K024137(SPECIAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 15-JAN-03
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)
GE MEDICAL SYSTEMS, INC. 510(k) NO: K024200(SPECIAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 16-JAN-03
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES
GENERAL GLOVES CORP. 510(k) NO: K024174(TRADITIONAL)
ATTN: JOHN CHEN PHONE NO : 886 6 6803675
25 PEI MA, 16 LIN TUNG CHUNG SE DECISION MADE: 28-JAN-03
VILLAGE, TUNG SHAN HSIANG 510(k) STATEMENT
TAINAN HSIEN, CHINA (TAIWAN) 733
DEVICE: GENZYME CONTRAST II HCG URINE/SERUM TEST
GENZYME CORP. 510(k) NO: K023544(TRADITIONAL)
ATTN: E.V. GOORCHENKO PHONE NO : 858-777-2614
ONE KENDALL SQUARE SE DECISION MADE: 16-JAN-03
CAMBRIDGE, MA 02139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VACUETTE TRACE ELEMENTS TUBES
GREINER BIO-ONE VACUETTE NORTH AME510(k) NO: K023971(TRADITIONAL)
ATTN: JUDI SMITH PHONE NO : 410-592-2060
PO BOX 103 SE DECISION MADE: 27-JAN-03
BALDWIN, MD 21013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
GUIDANT CORP. 510(k) NO: K030019(SPECIAL)
ATTN: KRISTINE M TEICH PHONE NO : 651-582-5011
4100 HAMLINE AVE., NORTH SE DECISION MADE: 24-JAN-03
ST. PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101
GVI TECHNOLOGY PARTNERS 510(k) NO: K023373(TRADITIONAL)
ATTN: KEVIN M NURROCK PHONE NO : 330-963-4083
1470 ENTERPRISE PARKWAY SE DECISION MADE: 03-JAN-03
TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HL888
HEALTH & LIFE CO., LTD. 510(k) NO: K023834(TRADITIONAL)
ATTN: SUSAN CHEN PHONE NO : 886 2 32349600
6F,NO.407, CHUNG SHAN RD. SE DECISION MADE: 14-JAN-03
SEC.02, CHUNG HO CITY 510(k) STATEMENT
TAIPEI HSIEN, CHINA (TAIWAN) 235 THIRD PARTY REVIEW
DEVICE: ALUMINA V40 FEMORAL HEADS
HOWMEDICA OSTEONICS CORP. 510(k) NO: K023901(TRADITIONAL)
ATTN: DEBRA BING PHONE NO : 201-831-5413
59 ROUTE 17 SE DECISION MADE: 28-JAN-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDROFERA BACTERIOSTATIC WOUND DRESSING
HYDROFERA, LLC. 510(k) NO: K023138(TRADITIONAL)
ATTN: HEATHER S BOND PHONE NO : 860-456-0677
322 MAIN ST., SUITE 1101 SE DECISION MADE: 17-JAN-03
WILLIMANTIC, CT 06226 510(k) STATEMENT
DEVICE: CONCERT CRANIOPLAST
IMMEDICA, INC. 510(k) NO: K023575(TRADITIONAL)
ATTN: RUSSELL PAGANO PHONE NO : 202-546-1262
719 A STREET, NE SE DECISION MADE: 22-JAN-03
WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS
IMPLEX CORP. 510(k) NO: K024161(SPECIAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 15-JAN-03
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CASSETTE/URINE HCG
IND DIAGNOSTIC INC. 510(k) NO: K023638(TRADITIONAL)
ATTN: DAVID LEE PHONE NO : 604 522 1619
1629 FOSTERS WAY SE DECISION MADE: 03-JAN-03
DELTA, B.C., CANADA V3M 6S7 510(k) STATEMENT
DEVICE: IVUS PLUS
INDEC SYSTEMS, INC. 510(k) NO: K024103(TRADITIONAL)
ATTN: CAROL HUBLER PHONE NO : 650-903-9755
505 E. EVELYN SE DECISION MADE: 24-JAN-03
SUITE D 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94041
DEVICE: CELSIUS CONTROL SYSTEM
INNERCOOL THERAPIES 510(k) NO: K022366(TRADITIONAL)
ATTN: STEVE REITZLER PHONE NO : 858-713-9507
3931 SORRENTO VALLEY BLVD. SE DECISION MADE: 27-JAN-03
SAN DIEGO,, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERFORMA STEREO
INSTRUMENTARIUM CORP. IMAGING DIVI510(k) NO: K023864(TRADITIONAL)
ATTN: BRIAN BRONCATTI PHONE NO : 414-747-1030
300 WEST EDGERTON AVENUE SE DECISION MADE: 09-JAN-03
MILWAUKEE, WI 53207 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSIL FACTOR V DEFICIENT PLASMA
INSTRUMENTATION LABORATORY CO. 510(k) NO: K023839(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 14-JAN-03
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTTROAE
INTELLIGENT HEARING SYSTEMS 510(k) NO: K023859(TRADITIONAL)
ATTN: EDWARD MISKIEL PHONE NO : 305-668-6102
7356 S.W. 48 ST. SE DECISION MADE: 08-JAN-03
MIAMI, FL 33155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
INTERNATIONAL TECHNIDYNE CORP. 510(k) NO: K023561(TRADITIONAL)
ATTN: JOHN CLAY PHONE NO : 800-272-1252
6 OLSEN AVE. SE DECISION MADE: 31-JAN-03
EDISON, NJ 08820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD)
INTERPORE CROSS INTL. 510(k) NO: K022143(TRADITIONAL)
ATTN: LYNN M RODARTI PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 23-JAN-03
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SW-180 SHORTWAVE THERAPY UNIT
ITO CO., LTD. 510(k) NO: K022846(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-570-0013
2305 GOLD MINE ROAD SE DECISION MADE: 28-JAN-03
BROOKEVILLE, MD 20833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LID CHAIN EYELID WEIGHTS
JEDMED INSTRUMENT CO. 510(k) NO: K021750(TRADITIONAL)
ATTN: CRAIG R PARKS PHONE NO : 314-845-3770
5416 JEDMED CT. SE DECISION MADE: 27-JAN-03
ST. LOUIS, MO 63129-2221 510(k) STATEMENT
DEVICE: ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT
JOHNSON & JOHNSON VISION CARE, INC510(k) NO: K024177(TRADITIONAL)
ATTN: JAMES W PARZIALE PHONE NO : 904-443-1808
7500 CENTURION PKWY. SE DECISION MADE: 22-JAN-03
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32256
DEVICE: JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS
JOSTRA AG 510(k) NO: K020784(TRADITIONAL)
ATTN: KATHLEEN JOHNSON PHONE NO : 610-932-7738
P.O. BOX 218 SE DECISION MADE: 09-JAN-03
OXFORD, PA 19363 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOWLINE BIOPORE EPTFE VASCULAR GRAFT
JOTEC GMBH 510(k) NO: K021547(TRADITIONAL)
ATTN: JOE SHARBER PHONE NO : 406-586-7666
2430 N. 7TH AVE. STE 4 SE DECISION MADE: 24-JAN-03
BOZEMAN, MT 59715 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA SCB ACC CONTROL
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K023704(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE 5TH FLOOR SE DECISION MADE: 30-JAN-03
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, K
KING SYSTEMS CORP. 510(k) NO: K021634(TRADITIONAL)
ATTN: TOM MCGRAIL PHONE NO : 800-642-5464
15011 HERRIMAN BLVD. SE DECISION MADE: 09-JAN-03
NOBLESVILLE, IN 46060 510(k) STATEMENT
DEVICE: AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500
KIRWAN SURGICAL PRODUCTS, INC. 510(k) NO: K023482(TRADITIONAL)
ATTN: KEVIN P PRARIO PHONE NO : 781-834-9500
180 ENTERPRISE DR. SE DECISION MADE: 15-JAN-03
MARSHFIELD, MA 02050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION
KL-KEPONG RUBBER PRODUCTS SDN. BHD510(k) NO: K023866(TRADITIONAL)
ATTN: YIM HOON PUNG PHONE NO : 605 357 1888
LADANG PINJI, BAHAGIAN SENGAT, SE DECISION MADE: 24-JAN-03
KAMPUNG KEPAYANG, 510(k) STATEMENT
IPOH, PERAK, DARUL RIDZUAN, MALAYSIA 31300
DEVICE: REEVUE INDIRECT CALORIMETER, MODEL#8100
KORR MEDICAL TECHNOLOGIES, INC. 510(k) NO: K021490(TRADITIONAL)
ATTN: SCOTT A KOFOED PHONE NO : 801-483-2080
3090 EAST 3300 SOUTH SE DECISION MADE: 02-JAN-03
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
SALT LAKE CITY, UT 84109
DEVICE: OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
LEMAITRE VASCULAR, INC. 510(k) NO: K022145(TRADITIONAL)
ATTN: JAMES ASHBY PHONE NO : 781-221-2266
26 RAY AVENUE SE DECISION MADE: 14-JAN-03
BURLINGTON, MA 01803 510(k) STATEMENT
DEVICE: LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER
LEMAITRE VASCULAR, INC. 510(k) NO: K023688(TRADITIONAL)
ATTN: JAMES ASHBY PHONE NO : 781-221-2266
26 RAY AVENUE SE DECISION MADE: 30-JAN-03
BURLINGTON, MA 01803 510(k) STATEMENT
DEVICE: SKINTACT
LEONHARD LANG CO. 510(k) NO: K024264(SPECIAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 16-JAN-03
STILLWATER, MN 55082-0560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKINTACT
LEONHARD LANG GMBH 510(k) NO: K023920(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 16-JAN-03
STILLWATER, MN 55082-0560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
LEONHARD LANG GMBH 510(k) NO: K024247(SPECIAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 16-JAN-03
STILLWATER, MN 55082-0560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70
LIDCO LTD. 510(k) NO: K023960(SPECIAL)
ATTN: GREGORY SPELLER PHONE NO : 44 020 77491500
16 ORSMAN RD. SE DECISION MADE: 09-JAN-03
LONDON, UNITED KINGDOM N15QJ 510(k) STATEMENT
DEVICE: LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002
LIMERICK, INC. 510(k) NO: K021739(TRADITIONAL)
ATTN: PATRICIA KELLY PHONE NO : 818-566-3060
903 NORTH SAN FERNANDO BLVD. SE DECISION MADE: 10-JAN-03
SUITE 5 510(k) SUMMARY AVAILABLE FROM FDA
BURBANK, CA 91504
DEVICE: PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K023795(TRADITIONAL)
ATTN: CHIU CHIN CHANG PHONE NO : 408-944-0360
2391 ZANKER RD., SUITE 340 SE DECISION MADE: 21-JAN-03
SAN JOSE, CA 95131-1124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIONEW-IV
LIVING DATA TECHNOLOGIES CORPORATI510(k) NO: K023701(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 30-JAN-03
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMEND FRONTRUNNER CTO CATHETER
LUMEND, INC. 510(k) NO: K023114(TRADITIONAL)
ATTN: MICHAEL A DANIEL PHONE NO : 650-364-1400
400 CHESAPEAKE DR. SE DECISION MADE: 23-JAN-03
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110
MAINE STANDARDS CO. 510(k) NO: K023410(TRADITIONAL)
ATTN: CHRISTINE BEACH PHONE NO : 207-892-1300
765 ROOSEVELT TRAIL SE DECISION MADE: 06-JAN-03
SUITE 9A 510(k) SUMMARY AVAILABLE FROM FDA
WINDHAM, ME 04062-5365
DEVICE: RTDOSEPLAN
MATH RESOLUTIONS, LLC. 510(k) NO: K022961(TRADITIONAL)
ATTN: WENDEL DEAN RENNER PHONE NO : 410-997-9578
5975 GALES LANE SE DECISION MADE: 31-JAN-03
COLUMBIA, MD 21045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 14
MEDI-GLOBE CORP. 510(k) NO: K010714(TRADITIONAL)
ATTN: GERHARDT SEIWERTH PHONE NO : 498 032 973345
MEDI-GLOB-STRASSE 1-5 SE DECISION MADE: 21-JAN-03
ACHENMUHLE, GERMANY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDS-4 NEUROMUSCULAR STIMULATOR
MEDICAL EQUIPMENT DEVICE SPECIALIS510(k) NO: K023435(TRADITIONAL)
ATTN: C. A. TEKLINSKI PHONE NO : 619-665-4912
32158 CAMINO CAPISTRANO SE DECISION MADE: 13-JAN-03
SUITE A-416 510(k) STATEMENT
SAN JUAN CAPISTRANO, CA 92675
DEVICE: MEDS-4 NEUROMUSCULAR STIMULATOR
MEDICAL EQUIPMENT DEVICE SPECIALIS510(k) NO: K023439(TRADITIONAL)
ATTN: DARREL BLOMBERG PHONE NO : 909-393-9427
32158 CAMINO CAPISTRANO SE DECISION MADE: 13-JAN-03
SUITE A-416 510(k) STATEMENT
SAN JUAN CAPISTRANO, CA 92675
DEVICE: MEDS-3 NEUROMUSCULAR STIMULATOR
MEDICAL EQUIPMENT DEVICE SPECIALIS510(k) NO: K023443(TRADITIONAL)
ATTN: DARREL BLOMBERG PHONE NO : 909-393-9427
32158 CAMINO CAPISTRANO SE DECISION MADE: 13-JAN-03
SUITE A-416 510(k) STATEMENT
SAN JUAN CAPISTRANO, CA 92675
DEVICE: MEDS-3 NEUROMUSCULAR STIMULATOR
MEDICAL EQUIPMENT DEVICE SPECIALIS510(k) NO: K023446(TRADITIONAL)
ATTN: DARREL BLOMBERG PHONE NO : 909-393-9427
32158 CAMINO CAPISTRANO SE DECISION MADE: 13-JAN-03
SUITE A-416 510(k) STATEMENT
SAN JUAN CAPISTRANO, CA 92675
DEVICE: PACSPLUS
MEDICAL STANDARD CO., LTD. 510(k) NO: K023460(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 214-262-4209
1100 LAKEVIEW BLVD. SE DECISION MADE: 09-JAN-03
DENTON, TX 76201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS
MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K023970(TRADITIONAL)
ATTN: J I HOLLANDER PHONE NO : 31 71 5223244
POORTGEBOUW RIJNSBURGERWEG 10 SE DECISION MADE: 24-JAN-03
LEIDEN, NETHERLANDS 2333 AA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL
MEDLOGIC GLOBAL LIMITED 510(k) NO: K023163(TRADITIONAL)
ATTN: HOWARD BEAUMONT PHONE NO : 441 752 209955
WESTERN WOOD WAY SE DECISION MADE: 13-JAN-03
LANGAGE SCIENCE PARK 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, DEVON, UNITED KINGDOM PL7 5BG
DEVICE: MEDRAD STELLANT CT INJECTOR SYSTEM
MEDRAD, INC. 510(k) NO: K023183(SPECIAL)
ATTN: FRANK W PELC III PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 10-JAN-03
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TO
MEDTRONIC CARDIAC SURGICAL PRODUCT510(k) NO: K022272(TRADITIONAL)
ATTN: ROGER BRINK PHONE NO : 616-643-7337
620 WATSON STREET SW SE DECISION MADE: 08-JAN-03
GRAND RAPIDS, MI 49504-6393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM
MEDTRONIC SURGICAL NAVIGATION TECH510(k) NO: K022126(TRADITIONAL)
ATTN: VICTORIA G RENDON PHONE NO : 720-890-3200
826 COAL CREEK CIR. SE DECISION MADE: 03-JAN-03
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIM-PRS
MEDTRONIC XOMED, INC. 510(k) NO: K024316(TRADITIONAL)
ATTN: MARTIN SARGENT PHONE NO : 904-934-7487
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 06-JAN-03
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
MEDTRONIC, INC. 510(k) NO: K023878(SPECIAL)
ATTN: FRED L BOUCHER PHONE NO : 978-777-0042
37A CHERRY HILL DRIVE SE DECISION MADE: 24-JAN-03
DANVERS, MA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106
MEDTRONIC, INC. 510(k) NO: K024069(SPECIAL)
ATTN: RONALD W BENNETT PHONE NO : 763-391-9086
7611 NORTHLAND DRIVE SE DECISION MADE: 08-JAN-03
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMUNOCARD STAT! E. COLI O157 PLUS
MERIDIAN BIOSCIENCE, INC. 510(k) NO: K023599(TRADITIONAL)
ATTN: SUSAN ROLIH PHONE NO : 513-271-3700
3471 RIVER HILLS DR. SE DECISION MADE: 03-JAN-03
CINCINNATI, OH 45244 510(k) STATEMENT
DEVICE: MICROVISION SCLERAL BUCKLING COMPONENTS
MICROVISION, INC. 510(k) NO: K023481(TRADITIONAL)
ATTN: SHEILA HEMEON-HEYER, JD, RAPHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 08-JAN-03
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILLEX VV, GV, AND HV SYRINGE FILTER UNITS
MILLIPORE CORP. 510(k) NO: K023892(TRADITIONAL)
ATTN: THOMAS BORROWS PHONE NO : 781-533-2622
80 ASHBY ROAD SE DECISION MADE: 17-JAN-03
BEDFORD, MA 01730 510(k) STATEMENT
DEVICE: BODY BOX 5500
MORGAN SCIENTIFIC, INC. 510(k) NO: K022636(TRADITIONAL)
ATTN: PATRICK F MORGAN PHONE NO : 978-521-4440
151 ESSEX ST. SE DECISION MADE: 13-JAN-03
HAVERHILL, MA 01832 510(k) STATEMENT
DEVICE: OBC-250-PAN BREAST ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K024208(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 07-JAN-03
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: QWH-250-PAN WRIST ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K024209(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 09-JAN-03
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM
MRI DEVICES CORP. 510(k) NO: K024352(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 09-JAN-03
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: PHSL-63-SYM AND PHS-63-SYM PEDIATRIC HEAD AND SPINE ARRAY COILS
MRI DEVICES CORP. 510(k) NO: K024354(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 09-JAN-03
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMEC
NEUROMECHANICAL INNOVATIONS, LLC 510(k) NO: K023462(TRADITIONAL)
ATTN: CHRISTOPHER J COLLOCA PHONE NO : 480-893-2400
11011 S. 48TH ST SE DECISION MADE: 13-JAN-03
SUITE 205 510(k) SUMMARY AVAILABLE FROM FDA
PHOENIX, AZ 85044
DEVICE: NUAMPS
NEUROSCAN 510(k) NO: K023536(ABBREVIATED)
ATTN: ELVIRA GARCIA PHONE NO : 915-845-5600
7850 PASEO DEL NORTE SE DECISION MADE: 15-JAN-03
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
EL PASO, TX 79912
DEVICE: NIKOMED TRACE 1 ECG ELECTRODES
NIKOMED U.S.A., INC. 510(k) NO: K022909(SPECIAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 09-JAN-03
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNIT
NOBEL BIOCARE USA, INC. 510(k) NO: K023952(TRADITIONAL)
ATTN: KATHELEEN DRAGOVICH PHONE NO : 714-282-4800
22715 SAVI RANCH PKWY. SE DECISION MADE: 16-JAN-03
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
NORTHGATE TECHNOLOGIES, INC. 510(k) NO: K022052(TRADITIONAL)
ATTN: CASEY KUREK PHONE NO : 847-608-8900
600 CHURCH RD. SE DECISION MADE: 24-JAN-03
ELGIN, IL 60123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAD, MODEL LAD-01
NORWOOD ABBEY , LTD. 510(k) NO: K021222(TRADITIONAL)
ATTN: ROBERT HANDREN PHONE NO : 352-314-8829
5818 PRINCESS CAROLINE PLACE SE DECISION MADE: 08-JAN-03
LEESBURG, FL 34748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENCLOSE ANASTOMOSIS ASSIST DEVICE
NOVARE SURGICAL SYSTEMS, INC. 510(k) NO: K023682(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 16-JAN-03
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389
DEVICE: VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V
OLYMPUS OPTICAL CO., LTD. 510(k) NO: K022445(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 24-JAN-03
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-SCAN 100
OPHTHALMIC TECHNOLOGIES, INC. 510(k) NO: K024114(SPECIAL)
ATTN: GEORGE H MYERS PHONE NO : 201-727-1703
377 RT 17 S SE DECISION MADE: 10-JAN-03
HASBROUCK HEIGHTS, NJ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K030067(TRADITIONAL)
ATTN: SARAH PARSONS PHONE NO : 585-453-3154
100 INDIGO CREEK DRIVE SE DECISION MADE: 17-JAN-03
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB
OSCOR INC. 510(k) NO: K024053(SPECIAL)
ATTN: MILA DOSKOCIL PHONE NO : 727-937-2511
3816 DE SOTO BLVD. SE DECISION MADE: 31-JAN-03
PALM HARBOR, FL 34683 510(k) STATEMENT
DEVICE: PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/
OSCOR INC. 510(k) NO: K024156(SPECIAL)
ATTN: MILA DOSKOCIL PHONE NO : 727-937-2511
3816 DE SOTO BLVD. SE DECISION MADE: 14-JAN-03
PALM HARBOR, FL 34683 510(k) STATEMENT
DEVICE: OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)
OSMETECH 510(k) NO: K023677(TRADITIONAL)
ATTN: ANDREW TUMMON PHONE NO : 440 127 0216444
ELECTRA HOUSE ELECTRA WAY SE DECISION MADE: 29-JAN-03
CREWE, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB
OSTEOMEDICS, INC. 510(k) NO: K022035(TRADITIONAL)
ATTN: ALBERT ENYATI PHONE NO : 201-444-7306
809 CARTER LANE SE DECISION MADE: 17-JAN-03
PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONICAID ONE
OXFORD INSTRUMENTS MEDICAL LTD. 510(k) NO: K023618(SPECIAL)
ATTN: MICHAEL EDWARDS PHONE NO : 44 148 3246277
MANOR WAY SE DECISION MADE: 22-JAN-03
OLD WOKING, SURREY, UNITED KINGDOM510(k) STATEMENT
DEVICE: PALOMAR Q-YAG ND:YAG LASER SYSTEM
PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K023967(TRADITIONAL)
ATTN: MARCY MOORE PHONE NO : 919-363-2432
131 KELEKENT LANE SE DECISION MADE: 27-JAN-03
CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GOLD CORE PLUS
PENTRON LABORATORY TECHNOLOGIES 510(k) NO: K023499(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 13-JAN-03
WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCULPTURE PLUS NANO-HYBRID COMPOSITE
PENTRON LABORATORY TECHNOLOGIES 510(k) NO: K023742(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 17-JAN-03
WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K024184(TRADITIONAL)
ATTN: JAMES F LOGAN PHONE NO : 410-837-1751
1301 DEFENCE HIGHWAY SE DECISION MADE: 14-JAN-03
GAMBRILLS, MD 21054 510(k) STATEMENT
DEVICE: ACCURA ELITE SHUNT SYSTEM
PHOENIX BIOMEDICAL CORP. 510(k) NO: K024040(SPECIAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
2495 GENERAL ARMISTEAD AVE. SE DECISION MADE: 27-JAN-03
P.O. BOX 80390 510(k) SUMMARY AVAILABLE FROM FDA
NORRISTOWN, PA 19403
DEVICE: PHOENIX UNIVERSAL SHUNT SYSTEM
PHOENIX BIOMEDICAL CORP. 510(k) NO: K024101(SPECIAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
2495 GENERAL ARMSTEAD AVE. SE DECISION MADE: 27-JAN-03
NORRISTOWN, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICUS ULTRASOUND IMAGING SYSTEMS
PIE MEDICAL 510(k) NO: K023512(TRADITIONAL)
ATTN: COLLEEN DENSMORE PHONE NO : 317-849-1916
SE DECISION MADE: 24-JAN-03
510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNI HIP STEM
PLUS ORTHOPEDICS 510(k) NO: K024134(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 15-JAN-03
ROUND ROCK, TX 78681-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECIMED HIP SCREW SYSTEM
PRECIMED, INC. 510(k) NO: K023851(TRADITIONAL)
ATTN: BARBARA LYONS PHONE NO : 610-524-8300
50 DEVYN DR. SE DECISION MADE: 28-JAN-03
CHESTER SPRINGS, PA 19425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UCC DENTAL MATERIAL
PRECIOUS CHEMICALS U.S.A., INC. 510(k) NO: K023790(TRADITIONAL)
ATTN: EUGENE LIEBERSTEIN PHONE NO : 203-329-1477
2151 LONG RIDGE RD. SE DECISION MADE: 21-JAN-03
STAMFORD, CT 06903 510(k) STATEMENT
DEVICE: UCP DENTAL MATERIAL
PRECIOUS CHEMICALS U.S.A., INC. 510(k) NO: K023831(TRADITIONAL)
ATTN: EUGENE LIEBERSTEIN PHONE NO : 203-329-1477
2151 LONG RIDGE RD. SE DECISION MADE: 24-JAN-03
STAMFORD, CT 06903 510(k) STATEMENT
DEVICE: GAS SAMPLING LINES
PROMEDIC, INC. 510(k) NO: K023579(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780
6329 WEST WATERVIEW CT. SE DECISION MADE: 28-JAN-03
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR
QUANTEL MEDICAL 510(k) NO: K023464(TRADITIONAL)
ATTN: ROGER W BARNES PHONE NO : 501-525-8612
342 SUNSET BAY ROAD SE DECISION MADE: 13-JAN-03
HOT SPRINGS, AR 71913 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIOMED MARKER
RADIOMED CORPORATION 510(k) NO: K022326(TRADITIONAL)
ATTN: GORDON ROBERTS PHONE NO : 978-649-0300
ONE INDUSTRIAL WAY SE DECISION MADE: 31-JAN-03
TYNGSBORO, MA 01879-1400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIONICS VARILINK 2
RADIONICS, A DIVISION OF TYCO HEAL510(k) NO: K023519(TRADITIONAL)
ATTN: KEVIN J O'CONNELL PHONE NO : 781-272-1233
22 TERRY AVE. SE DECISION MADE: 16-JAN-03
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTR
RANDOX LABORATORIES, LTD. 510(k) NO: K023763(TRADITIONAL)
ATTN: LYNNE HAMILTON PHONE NO : 440 289 4422413
ARDMORE, DIAMOND ROAD SE DECISION MADE: 13-JAN-03
CRUMLIN, CO. ANTRIM, UNITED KINGDO510(k) STATEMENT
DEVICE: LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING H
REHABILITATION INSTITUTE,LOMA LIND510(k) NO: K023572(TRADITIONAL)
ATTN: LYNN D FLEISHER PHONE NO : 312-853-2065
BANK ONE PLAZA, 10 S. DEARBORN SE DECISION MADE: 13-JAN-03
CHICAGO, IL 60603 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMECURE MODEL CL 15E
REMEDENT NV 510(k) NO: K023652(TRADITIONAL)
ATTN: ED FIRST PHONE NO : 949-421-0120
20992 BAKE PKWY SE DECISION MADE: 09-JAN-03
UNIT 102 510(k) STATEMENT
LAKE FOREST, CA 92692
DEVICE: IMAGE3 SE DISPOSABLE FULL FACE MASK
RESPIRONICS, INC. 510(k) NO: K023135(ABBREVIATED)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LANE SE DECISION MADE: 03-JAN-03
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: H2 HEATED HUMIDIFIER
RESPIRONICS, INC. 510(k) NO: K030090(TRADITIONAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LANE SE DECISION MADE: 24-JAN-03
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INNER-LOCK LOCKING INTRODUCER SHEATHS
REX MEDICAL 510(k) NO: K022170(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 21-JAN-03
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: 1-CCD ENDOCAM 5520 SYSTEM
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K023659(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 29-JAN-03
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIPOLAR FORCEPS
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K023813(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 17-JAN-03
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 G
ROCKWELL MEDICAL TECHNOLOGIES, INC510(k) NO: K022521(TRADITIONAL)
ATTN: DONALD DANALD PHONE NO : 248-960-9009
30142 WIXOM ROAD SE DECISION MADE: 03-JAN-03
WIXOM, MI 48393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30
RUBICOR MEDICAL, INC. 510(k) NO: K030049(SPECIAL)
ATTN: ROBERT J CHIN PHONE NO : 650-593-5225
25 HARTFORD AVENUE SE DECISION MADE: 29-JAN-03
SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAS RSV TEST
SA SCIENTIFIC, INC. 510(k) NO: K022845(TRADITIONAL)
ATTN: RICARDO R MARTINEZ PHONE NO : 210-699-8800
4919 GOLDEN QUAIL SE DECISION MADE: 29-JAN-03
SAN ANTONIO, TX 78240 510(k) STATEMENT
DEVICE: DISPOSBLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA
SAFEHEALTH MEDICAL SUPPLY CORP. 510(k) NO: K024081(TRADITIONAL)
ATTN: P.M. YEH PHONE NO : 011 886 67832197
NO. 1,TOU KANG LI, SE DECISION MADE: 28-JAN-03
HSUEH CHIA COUNTY 510(k) STATEMENT
TAINAN HSIEN, CHINA (TAIWAN)
DEVICE: NEOGENESYS 2K
SANEXAS INTL. GMBH 510(k) NO: K022433(TRADITIONAL)
ATTN: GENE KELLY PHONE NO : 816-347-9224
200 NE MULBERRY SE DECISION MADE: 24-JAN-03
LEE'S SUMMIT, MO 64086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE-POWDERED LATEX SURGEON'S GLOVES
SANREA HEALTHCARE PRIVATE LIMITED 510(k) NO: K023515(TRADITIONAL)
ATTN: JOSE PAUL M PHONE NO : 91 484 422514
COCHIN SPECIAL ECONOMIC ZONE SE DECISION MADE: 16-JAN-03
KAKKANAD, COCHIN 510(k) STATEMENT
KERALA, INDIA 682037
DEVICE: BIOSORB RESORBABLE VOID FILLER
SCIENCES ET BIO MATERIAUX (SBM) 510(k) NO: K021963(TRADITIONAL)
ATTN: DENIS CLEMENT PHONE NO : 335 624 22101
ZI DU MONGE SE DECISION MADE: 28-JAN-03
LORDES, FRANCE F 65100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G
SECHRIST INDUSTRIES, INC. 510(k) NO: K023745(TRADITIONAL)
ATTN: GREG GODFREY PHONE NO : 714-579-8318
4225 EAST LA PALMA SE DECISION MADE: 17-JAN-03
ANAHEIM, CA 92807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
SECURE SCIENTIFIC SDN BHD 510(k) NO: K023128(ABBREVIATED)
ATTN: CHONG NGIT-HENG PHONE NO : 604 484 3987
LOT 122, KAMPUNG TITI TOK ARIS SE DECISION MADE: 22-JAN-03
SUNGAI SELUANG 510(k) STATEMENT
LUNAS, KEDAH, MALAYSIA 09600
DEVICE: PEGASUS NASAL CPAP SYSTEM
SENSORMEDICS CORP. 510(k) NO: K022192(TRADITIONAL)
ATTN: PAUL L KITTINGER PHONE NO : 714-283-2228
22705 SAVI RANCH PKWY. SE DECISION MADE: 24-JAN-03
YORBA LINDA, CA 92887-4645 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACROSEAL ROOT CANAL OR APICAL SEALER
SEPTODONT S.A.S. 510(k) NO: K023976(TRADITIONAL)
ATTN: WAYNE H MATELSKI PHONE NO : 202-857-6340
1050 CONNECTICUT AVE NW SE DECISION MADE: 30-JAN-03
WASHINGTON, DC 20036 510(k) STATEMENT
DEVICE: SHANGHAI HUAMAO POWDER-FREE YELLOW VINYL EXAM GLOVES
SHANGHAI HUAMAO GLOVES CO., LTD. 510(k) NO: K024154(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 06-JAN-03
GREAT NECK, NY 11021 510(k) STATEMENT
DEVICE: SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K023743(ABBREVIATED)
ATTN: JANET JOHNSON AKIL PHONE NO : 901-399-5153
1450 E. BROOKS ROAD SE DECISION MADE: 23-JAN-03
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SODEM HIGH SPEED SYSTEM (PNEUMATIC)
SODEM SYSTEMS 510(k) NO: K023070(TRADITIONAL)
ATTN: CAROLE BURNIER PHONE NO : 41 22 7949696
110 CH. DU PONT DU CENTENAIRE SE DECISION MADE: 28-JAN-03
GENEVA, SWITZERLAND CH-1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT
SOFTFOCAL COMPANY, INC. 510(k) NO: K023791(TRADITIONAL)
ATTN: ROBERT B MANDELL PHONE NO : 925-376-4724
69 SULLIVAN DRIVE SE DECISION MADE: 10-JAN-03
MORAGA, CA 94556 510(k) STATEMENT
DEVICE: HCP DICOM NET
SOFTLINK INTERNATIONAL INC. 510(k) NO: K023467(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD SE DECISION MADE: 07-JAN-03
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: SOLA, COUNTER-PULSATION, MODEL SECP-S
SOLA MEDICAL DEVICES, LLC 510(k) NO: K022078(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE SAUSALITO SE DECISION MADE: 10-JAN-03
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY
SONOSITE,INC. 510(k) NO: K030064(TRADITIONAL)
ATTN: MICHAEL A HOFFMAN PHONE NO : 425-951-1297
21919 30TH DRIVE SE. SE DECISION MADE: 22-JAN-03
BOTHELL, WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MBC SERIES
SORING GMBH MEDIZINTECHNIK 510(k) NO: K024059(SPECIAL)
ATTN: CARL ALLETTO PHONE NO : 214-262-4209
1100 LAKEVIEW BLVD. SE DECISION MADE: 08-JAN-03
DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPC BY SORING GMBH
SORING GMBH MEDIZINTECHNIK 510(k) NO: K030028(SPECIAL)
ATTN: CARL ALLETTO PHONE NO : 214-262-4209
1100 LAKEVIEW BLVD. SE DECISION MADE: 17-JAN-03
DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECATH CENTRAL VENOUS CATHETER KITS
SPECIAL MEDICAL CO. LTD. 510(k) NO: K021130(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 07-JAN-03
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SY
SPINAL CONCEPTS, INC. 510(k) NO: K024326(SPECIAL)
ATTN: LISA PETERSON PHONE NO : 512-918-2700
5301 RIATA PARK COURT SE DECISION MADE: 23-JAN-03
BLDG F 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78727
DEVICE: PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLA
STARMATRIX SDN BHD 510(k) NO: K023977(TRADITIONAL)
ATTN: NGAN BOON SENG PHONE NO : 603 339 26168
10, JALAN SS 1/26 SE DECISION MADE: 24-JAN-03
PETALING JAYA, SELANGOR, MALAYSIA 510(k) STATEMENT
DEVICE: NITRILE EXAMINATION GLOVES, POWDER FREE
STARMATRIX SDN BHD 510(k) NO: K023978(TRADITIONAL)
ATTN: NGAN BOON SENG PHONE NO : 603 339 26168
10, JALAN SS 1/26 SE DECISION MADE: 24-JAN-03
PETALING JAYA, SELANGOR, MALAYSIA 510(k) STATEMENT
DEVICE: NITRILE EXAMINATION GLOVES, PRE-POWDERED
STARMATRIX SDN BHD 510(k) NO: K023979(TRADITIONAL)
ATTN: NGAN GOON SENG PHONE NO : 603 339 26168
10, JALAN SS 1/26 SE DECISION MADE: 24-JAN-03
PETALING JAYA, SELANGOR, MALAYSIA 510(k) STATEMENT
DEVICE: STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM
STEREOTAXIS, INC. 510(k) NO: K021555(TRADITIONAL)
ATTN: PETER A TAKES PHONE NO : 314-615-6964
4041 FOREST PARK AVENUE SE DECISION MADE: 15-JAN-03
ST. LOUIS, MO 63108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM
STERNGOLD 510(k) NO: K023580(ABBREVIATED)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 17-JAN-03
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER NAVIGATION SYSTEM - HIP MODULE
STRYKER INSTRUMENTS 510(k) NO: K022365(TRADITIONAL)
ATTN: KELLI BITTERBURG PHONE NO : 616-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 22-JAN-03
KALAMAZOO, MI 49001-6197 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-INVASIVE PATIENT FIXATION SYSTEM
STRYKER LEIBINGER 510(k) NO: K023449(TRADITIONAL)
ATTN: KELLI J BITTERBURG PHONE NO : 877-534-2464
4100 EAST MILHAM AVE SE DECISION MADE: 13-JAN-03
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFEDOP DOPPLER
SUMMIT DOPPLER SYSTEMS, INC. 510(k) NO: K024197(TRADITIONAL)
ATTN: KEN JARRELL PHONE NO : 303-423-7572
5350 VIVIAN ST., SUITE A SE DECISION MADE: 03-JAN-03
ARVADA, CO 80002-1957 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPER
SUPERMAX GLOVE MANUFACTURING SDN B510(k) NO: K024083(TRADITIONAL)
ATTN: STANLEY THAI PHONE NO : 603 615 72328
LOT 42, PUTRA INDUSTRIAL PARK SE DECISION MADE: 10-JAN-03
BUKIT RAHMAN PUTRA 510(k) STATEMENT
SUNGAI BULOH, SELANGOR, MALAYSIA 47000
DEVICE: MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES
SURGICAL INSTRUMENTS SERVICE AND S510(k) NO: K030179(ABBREVIATED)
ATTN: MARY ANN BARKER PHONE NO : 541-549-4164
723 CURTIS CT; PO BOX 2060 SE DECISION MADE: 24-JAN-03
SISTERS, OR 97759 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/00
SURGICAL LASER TECHNOLOGIES, INC. 510(k) NO: K023624(TRADITIONAL)
ATTN: DAVIS WOODWARD PHONE NO : 215-619-3600
147 KEYSTONE DR. SE DECISION MADE: 27-JAN-03
MONTGOMERYVILLE, PA 18936 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR
SYNTEX HEALTHCARE PRODUCTS CO. LTD510(k) NO: K023826(TRADITIONAL)
ATTN: TAN SWU CHOON PHONE NO : 863 113 270666
NO. 1 FANJIAZHUNG INDUSTRIAL SE DECISION MADE: 24-JAN-03
ZONE 510(k) STATEMENT
XINJI CITY, HEBEI PROVINCE, CHINA 052360
DEVICE: SYNTHES RESORBABLE CONTOURABLE MESH
SYNTHES (USA) 510(k) NO: K022844(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 07-JAN-03
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM
SYNTHES (USA) 510(k) NO: K023802(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 28-JAN-03
POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYNTHES TOMOFIX OSTEOTOMY SYSTEM
SYNTHES (USA) 510(k) NO: K023941(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 23-JAN-03
POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: TATUNG TMD-26AX SERIES TENS, MODELS NO. TMD-26AB TATUNG TENS (BL
TATUNG CO. 510(k) NO: K021794(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 13-JAN-03
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEH LIN JUPITER POWER CHAIR, MODEL TL-320
TEH LIN PROSTHETIC & ORTHOPAEDIC, 510(k) NO: K022697(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 24-JAN-03
HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERABYTE 2000 HAIR REMOVER
TERABYTE CO. 510(k) NO: K022341(TRADITIONAL)
ATTN: WILLIAM A OLSON PHONE NO : 703-590-7337
5200 WOLF RUN SHOALS ROAD SE DECISION MADE: 27-JAN-03
WOODBRIDGE, VA 22192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM
TERATECH CORP. 510(k) NO: K030191(TRADITIONAL)
ATTN: CHARLES F HOTTINGER PHONE NO : 408-741-1006
77-79 TERRACE HALL AVE. SE DECISION MADE: 29-JAN-03
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TRILUMINA THERAPEUTIC LASER SYSTEM
TEXAS APPLIED BIOMEDICAL SERVICES 510(k) NO: K023935(TRADITIONAL)
ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433
12101-A CULLEN BLVD. SE DECISION MADE: 28-JAN-03
HOUSTON, TX 77047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE H
THE BINDING SITE, LTD. 510(k) NO: K023009(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
EAST TOWER, SUITE 600 SE DECISION MADE: 21-JAN-03
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: FREELITE HUMAN LAMBDA FREE KIT
THE BINDING SITE, LTD. 510(k) NO: K023131(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 21-JAN-03
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIE
THE OLYMPUS OPTICAL CO. 510(k) NO: K023984(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE DRIVE SE DECISION MADE: 31-JAN-03
MELVILLE, NY 11747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM
THERALIGHT, INC. 510(k) NO: K024020(TRADITIONAL)
ATTN: KEVIN E DALY PHONE NO : 760-930-8000
2794 LOKER AVE. WEST,SUITE 105 SE DECISION MADE: 17-JAN-03
CARLSBAD, CA 92008-6616 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RSV OIA
THERMO BIOSTAR, INC. 510(k) NO: K023779(TRADITIONAL)
ATTN: JOHN G ADAMS PHONE NO : 303-530-3888
331 SOUTH 104TH STREET SE DECISION MADE: 14-JAN-03
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALIBRATION PACK, MODELS A9100-101S AND A9100-103S
THERMO ORION 510(k) NO: K023792(TRADITIONAL)
ATTN: PATRICK K CHIU PHONE NO : 978-232-1067
500 CUMMINGS CENTER SE DECISION MADE: 31-JAN-03
BEVERLY, MA 01915-6199 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TROPHYPAN
TROPHY RADIOLOGIE 510(k) NO: K023346(TRADITIONAL)
ATTN: MARIE-PIERRE LABAT-CAMY PHONE NO : 331 648 08500
4 RUE F. PELLOUTIER CROISSY SE DECISION MADE: 03-JAN-03
BEAUBOURG 510(k) STATEMENT
MARNE LA VALLEE CEDEX 2, FRANCE 77437
DEVICE: ULTROID HEMORRHOID MANAGEMENT SYSTEM
ULTROID, LLC 510(k) NO: K023706(TRADITIONAL)
ATTN: RONALD R NEWTON PHONE NO : 775-841-4333
2230 DAMON RD. SE DECISION MADE: 14-JAN-03
CARSON CITY, NV 89701 510(k) STATEMENT
DEVICE: UNIPACS WORKSTATION
UNIVERSAL PACS, INC. 510(k) NO: K023476(TRADITIONAL)
ATTN: JOHN M TYLER PHONE NO : 225-766-9381
127 ALBERT HART DRIVE SE DECISION MADE: 07-JAN-03
BATON ROUGE, LA 70803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL
USA INSTRUMENTS, INC. 510(k) NO: K023650(TRADITIONAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 24-JAN-03
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BURBANK TENACULUM, MODEL 09-0011-01
VASCULAR CONTROL SYSTEMS, INC 510(k) NO: K030078(TRADITIONAL)
ATTN: AL MEMMOLO PHONE NO : 949-488-8700
32236 PASEO ADELANTO, STE. E SE DECISION MADE: 24-JAN-03
SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM
VISION-SCIENCES, INC. 510(k) NO: K024095(SPECIAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 09-JAN-03
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOUSSIGNAC C.P.A.P. DEVICE
VYGON S A 510(k) NO: K013884(TRADITIONAL)
ATTN: LAETITIA BERNARD PHONE NO : 909-699-6262
45900 PARSIPPANY COURT SE DECISION MADE: 21-JAN-03
TEMECULA, CA 92592 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX 90
WE DONG MYUNG DENTAL INDUSTRIAL CO510(k) NO: K030206(TRADITIONAL)
ATTN: RONALD D ARKIN PHONE NO : 770-565-6166
1733 CANTON LANE SE DECISION MADE: 29-JAN-03
MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271
WIENER LABORATORIES S.A.I.C. 510(k) NO: K023744(TRADITIONAL)
ATTN: VIVIANA CETOLA PHONE NO : 54 341 4329191
2944 RIOBAMBA SE DECISION MADE: 03-JAN-03
ROSARIO, ARGENTINA 2000 510(k) STATEMENT
DEVICE: ENDOSCOPIC LIGHT SOURCE XL180/L3
WORLD OF MEDICINE LEMKE GMBH 510(k) NO: K023468(TRADITIONAL)
ATTN: SUSANNE RAAB PHONE NO : 617-868-3995
91 TROWBRIDGE STREET SE DECISION MADE: 14-JAN-03
CAMBRIDGE, MA 02138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K023490(TRADITIONAL)
ATTN: YUE WAH CHOW PHONE NO : 60 3 87061486
LOT 1, JALAN 3, SE DECISION MADE: 16-JAN-03
KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA
SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900
DEVICE: WU'S 3-WHEELED NEO SCOOTER, WT-L3
WU'S TECH CO., LTD. 510(k) NO: K023040(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 866 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 24-JAN-03
HSIN-CHU CITY, CHINA (TAIWAN) ROC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WU'S 3-WHEELED NEO SCOOTER, WT-M4
WU'S TECH CO., LTD. 510(k) NO: K023166(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 24-JAN-03
HSIN-CHU CITY, CHINA (TAIWAN) ROC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WU'S 3-WHEELED NEO SCOOTER, WT-T3B
WU'S TECH CO., LTD. 510(k) NO: K023168(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 24-JAN-03
NSIN-CHU CITY, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAYBE?MOM MINI PVULATION MICROSCOPE
LEC ASSOCIATES 510(k) NO: K013582
ATTN: TONI MILLER PHONE NO : 201-785-1882
22 CHURCH STREET SE DECISION MADE: 16-JAN-03
SUITE 103-224 510 (k) STATEMENT
RAMSEY, NJ 07446
TOTAL 510(k)s THIS PERIOD 297
TOTAL WITH SUMMARIES 222
TOTAL WITH STATEMENTS 75
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