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510(k)s Final Decisions Rendered for August 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-AUG-2003 THROUGH 31-AUG-2003
DEVICE: POLY Q (GARANT L, PENTA M, PENTA H)
3M ESPE AG DENTAL PRODUCTS 510(k) NO: K032001(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 11-AUG-03
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELCACAM
A-DEC, INC. 510(k) NO: K032070(TRADITIONAL)
ATTN: TOM LOUISELL PHONE NO : 503-538-9471
2601 CRESTVIEW DR. SE DECISION MADE: 27-AUG-03
NEWBERG, OR 97132-9257 510(k) STATEMENT
DEVICE: ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND AC
ACON LABORATORIES, INC. 510(k) NO: K031759(SPECIAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 04-AUG-03
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOBILE BATTERY SERVICE STATION (MBSS)
AD ELEKTRONIK GMBH 510(k) NO: K030898(TRADITIONAL)
ATTN: RICHARD TOOTCHEN PHONE NO : 856-374-8837
33 STEEPLECHASE DR. SE DECISION MADE: 27-AUG-03
TUNERSVILLE, NJ 08012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERRAD 200 STERILIZER
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K030429(TRADITIONAL)
ATTN: NATALIE BENNINGTON PHONE NO : 949-453-6482
33 TECHNOLOGY DR. SE DECISION MADE: 18-AUG-03
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLUMBUS (PS)
AESCULAP, INC. 510(k) NO: K030367(TRADITIONAL)
ATTN: JOYCE KILROY PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 21-AUG-03
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP
AESCULAP, INC. 510(k) NO: K032198(SPECIAL)
ATTN: MATTHEW M HULL PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 20-AUG-03
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROPHYSIOLOGY CATHETER
ALLIANCE MEDICAL CORP. 510(k) NO: K030109(TRADITIONAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5300
10232 SOUTH 51ST ST. SE DECISION MADE: 08-AUG-03
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295
ALSIUS CORP. 510(k) NO: K014241(TRADITIONAL)
ATTN: KEN COLLINS PHONE NO : 949-453-0150
15770 LAGUNA CANYON, SUITE 150 SE DECISION MADE: 01-AUG-03
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTATEC CERAMIC ABUTMENT
ALTATEC BIOTECHNOLOGIES 510(k) NO: K032448(SPECIAL)
ATTN: ROBERT SLOMOFF PHONE NO : 301-983-1707
9229 CRANFORD DR. SE DECISION MADE: 22-AUG-03
POTOMAC, MD 20854 510(k) STATEMENT
DEVICE: NX SYSTEM
AMERICAN TELECARE, INC. 510(k) NO: K030222(TRADITIONAL)
ATTN: PETE PLUCINAK PHONE NO : 952-897-0000
7640 GOLDEN TRIANGLE DR. SE DECISION MADE: 19-AUG-03
EDEN PRAIRIE, MN 55344-3732 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
AMERIWATER 510(k) NO: K021560(TRADITIONAL)
ATTN: BRAIN R BOWMAN PHONE NO : 937-461-8833
1257 STANLEY AVE. SE DECISION MADE: 14-AUG-03
DAYTON, OH 45404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHE
ANGIODYNAMICS, INC. 510(k) NO: K032069(SPECIAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 27-AUG-03
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER
ANGIODYNAMICS, INC. 510(k) NO: K032376(SPECIAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 26-AUG-03
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: OLYMPUS ULTRASONIC SURGICAL SYSTEM
AOMORI OLYMPUS CO., LTD. 510(k) NO: K031710(TRADITIONAL)
ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5688
2 CORPORATE CENTER DR. SE DECISION MADE: 29-AUG-03
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 14G CORMARK BIOPSY SITE IDENTIFIER
ARTEMIS MEDICAL, INC. 510(k) NO: K032217(SPECIAL)
ATTN: LINDA GUTHRIE PHONE NO : 510-259-3155
21021 CORSAIR BLVD. SE DECISION MADE: 21-AUG-03
HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE SYSTEM
ARTHROCARE CORP. 510(k) NO: K032504(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-735-6426
680 VAQUEROS AVE. SE DECISION MADE: 21-AUG-03
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUSAM TOTAL ALBUMIN ASSAY
AUSAM BIOTECTHNOLOGIES INC 510(k) NO: K013643(TRADITIONAL)
ATTN: STEVEN W ALLIS PHONE NO : 202-756-8141
600 THIRTEENTH ST., N.W. SE DECISION MADE: 14-AUG-03
WASHINGTON,, DC 20005 510(k) STATEMENT
DEVICE: ULTRASITE VALVE
B. BRAUN MEDICAL, INC. 510(k) NO: K031923(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-596-2375
901 MARCON BLVD. SE DECISION MADE: 11-AUG-03
ALLENTOWN, PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TRELLIS RESERVE INFUSION SYSTEM (140CM CATHETER
BACCHUS VASCULAR, INC. 510(k) NO: K032261(SPECIAL)
ATTN: GREGORY J MATHISON PHONE NO : 408-980-8300
3110 CORONADO DR. SE DECISION MADE: 22-AUG-03
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
BAXTER HEALTHCARE CORP. 510(k) NO: K031566(TRADITIONAL)
ATTN: JENNIFER M PAINE PHONE NO : 847-270-5825
ONE BAXTER PKWY. SE DECISION MADE: 19-AUG-03
DEERFIELD, IL 60015-4633 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOX AMMONIA CALIBRATOR
BAYER HEALTHCARE, LLC 510(k) NO: K031683(ABBREVIATED)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE. SE DECISION MADE: 06-AUG-03
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVISOR, MODEL 9200
BCI, INC. 510(k) NO: K030407(TRADITIONAL)
ATTN: DONALD ALEXANDER PHONE NO : 262-542-3100
N7 W22025 JOHNSON RD. SE DECISION MADE: 19-AUG-03
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER
BCI, INC. 510(k) NO: K031742(TRADITIONAL)
ATTN: DONALD J ALEXANDER PHONE NO : 262-542-3100
N7 W22025 JOHNSON RD. SE DECISION MADE: 18-AUG-03
WAUKESHA, WI 53186-1856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCO MIC AND MIC/ID PANELS
BD DIAGNOSTIC SYSTEMS 510(k) NO: K032259(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 303-390-3240
12750 W. 42ND AVENUE SE DECISION MADE: 19-AUG-03
WHEAT RIDGE, CO 80033-2440 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COULTER LH 500 HEMATOLOGY ANALYZER
BECKMAN COULTER, INC. 510(k) NO: K032000(ABBREVIATED)
ATTN: STAN SUGRUE PHONE NO : 305-380-4552
11800 SW 147TH AVE. SE DECISION MADE: 13-AUG-03
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYST
BECKMAN COULTER, INC. 510(k) NO: K032035(TRADITIONAL)
ATTN: KIM WALKER PHONE NO : 714-961-4912
200 SOUTH KRAEMER BLVD.,W-104 SE DECISION MADE: 07-AUG-03
BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY
BECKMAN COULTER, INC. 510(k) NO: K032162(SPECIAL)
ATTN: LYNN WEIST PHONE NO : 952-368-1271
1000 LAKE HAZELTINE DR. SE DECISION MADE: 08-AUG-03
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 A
BECKMAN COULTER, INC. 510(k) NO: K032287(SPECIAL)
ATTN: KIM WALKER PHONE NO : 714-961-4912
200 S. KRAEMER BLVD.,M/S W-104 SE DECISION MADE: 18-AUG-03
BOX 8000 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92822-8000
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64
BECTON, DICKINSON AND COMPANY 510(k) NO: K031943(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 06-AUG-03
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML
BECTON, DICKINSON AND COMPANY 510(k) NO: K031984(TRADITIONAL)
ATTN: KATHRYN BABKA POWERS PHONE NO : 410-316-4260
7 LOVETON CIR. SE DECISION MADE: 27-AUG-03
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-
BECTON, DICKINSON AND COMPANY 510(k) NO: K032131(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 18-AUG-03
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTISEPTIC HPC
BETHEL, INC 510(k) NO: K031851(TRADITIONAL)
ATTN: ERIC WADE PHONE NO : 903-372-1838
320 S. VINE AVENUE SE DECISION MADE: 01-AUG-03
TYLER, TX 75702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BINDER CO2 INCUBATOR SERIE CB
BINDER GMBH 510(k) NO: K032526(TRADITIONAL)
ATTN: PAUL DISTLER PHONE NO : 497 461 17920
BERGSTRASSE 14 SE DECISION MADE: 29-AUG-03
TUTTLINGEN, GERMANY D-78532 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NEUROTECH BAXOLVE TYPE 294
BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K023913(TRADITIONAL)
ATTN: MICHELLE SAWYER PHONE NO : 353 917 74361
BMR HOUSE SE DECISION MADE: 25-AUG-03
PARKMORE BUSINESS PARK WEST 510(k) SUMMARY AVAILABLE FROM FDA
GALWAY, IRELAND
DEVICE: LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3
BIO-RAD 510(k) NO: K032017(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367
9500 JERONIMO RD. SE DECISION MADE: 08-AUG-03
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-10 HEMOGLOBIN A1C
BIO-RAD LABORATORIES, INC. 510(k) NO: K031043(TRADITIONAL)
ATTN: JACKIE BUCKLEY PHONE NO : 510-741-5309
4000 ALFRED NOBEL DR. SE DECISION MADE: 27-AUG-03
HERCULES, CA 94547 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1
BIOMEDICAL LIFE SYSTEMS, INC. 510(k) NO: K031427(TRADITIONAL)
ATTN: RICHARD SAXON PHONE NO : 760-727-5600
P.O. BOX 1360 SE DECISION MADE: 19-AUG-03
VISTA, CA 92085-1360 510(k) STATEMENT
DEVICE: VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE
BIOMERIEUX, INC. 510(k) NO: K031865(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695
595 ANGLUM RD. SE DECISION MADE: 13-AUG-03
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 GRAM POSITIVE GATIFLOXACIN
BIOMERIEUX, INC. 510(k) NO: K032314(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695
595 ANGLUM DR. SE DECISION MADE: 22-AUG-03
HAZELWOOD, MO 63042-2320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM;
BIOMET, INC. 510(k) NO: K030055(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 11-AUG-03
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA
BIOMET, INC. 510(k) NO: K031693(TRADITIONAL)
ATTN: PATRICIA S BERES PHONE NO : 574-267-6639
56 BELL DR. SE DECISION MADE: 06-AUG-03
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS
BIOMET, INC. 510(k) NO: K032396(SPECIAL)
ATTN: GARY BAKER PHONE NO : 574-372-1568
56 EAST BELL DR. SE DECISION MADE: 21-AUG-03
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL
BIONOSTICS, INC. 510(k) NO: K032453(TRADITIONAL)
ATTN: KATHLEEN STORRO PHONE NO : 978-772-7070
7 JACKSON RD. SE DECISION MADE: 28-AUG-03
DEVENS, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUET SYSTEM
BIOVIEW LTD. 510(k) NO: K030192(TRADITIONAL)
ATTN: ORLY MAOR PHONE NO : 972 977 18130
117 AHUZAH ST. SE DECISION MADE: 20-AUG-03
RA'ANANNA, ISRAEL 76703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIVAC KIT
BOSTON SCIENTIFIC CORP. 510(k) NO: K032050(TRADITIONAL)
ATTN: RONALD C ALLEN PHONE NO : 408-895-3500
2710 ORCHARD PKWY. SE DECISION MADE: 08-AUG-03
SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IQ HYDROPHILIC GUIDE WIRE
BOSTON SCIENTIFIC CORP. 510(k) NO: K032183(SPECIAL)
ATTN: ANNE V ROSSI PHONE NO : 763-494-2827
ONE SCIMED PLACE SE DECISION MADE: 01-AUG-03
MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBRA COOLED SURGICAL PROBE, MODEL M004159670
BOSTON SCIENTIFIC CORP. 510(k) NO: K032207(SPECIAL)
ATTN: APRIL I MALMBORG PHONE NO : 408-895-3637
2710 ORCHARD PKWY. SE DECISION MADE: 20-AUG-03
SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED
BOSTON SCIENTIFIC CORP. 510(k) NO: K032360(SPECIAL)
ATTN: TODD KORNMANN PHONE NO : 763-494-2467
ONE SCIMED PLACE SE DECISION MADE: 27-AUG-03
MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAXCEL PORT, MODELS 45-336 AND 45-338
BOSTON SCIENTIFIC CORP. 510(k) NO: K032375(SPECIAL)
ATTN: JODI LYNN GREENIZEN PHONE NO : 518-742-4338
10 GLENS FALLS TECHNICAL PARK SE DECISION MADE: 19-AUG-03
GLENS FALLS, NY 12801-3864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUGLIELMI DETACHABLE COIL (GDC)
BOSTON SCIENTIFIC, TARGET 510(k) NO: K031049(TRADITIONAL)
ATTN: ROXANE BAXTER PHONE NO : 510-624-2105
47900 BAYSIDE PKWY. SE DECISION MADE: 01-AUG-03
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CI TKR/UKR
BRAINLAB, AG 510(k) NO: K031770(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680
AMMERTHALSTRASSE 8 SE DECISION MADE: 12-AUG-03
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
BRANAN MEDICAL CORP. 510(k) NO: K032057(SPECIAL)
ATTN: RAPHAEL WONG PHONE NO : 949-598-7166
10015 MUIRLANDS RD., SUITE E SE DECISION MADE: 21-AUG-03
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: JOBST TRAVEL SOCKS
BSN-JOBST, INC. 510(k) NO: K032325(TRADITIONAL)
ATTN: ANGELO PEREIRA PHONE NO : 704-551-7178
5825 CARNEGIE BLVD. SE DECISION MADE: 28-AUG-03
CHARLOTTE, NC 28209-4633 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER
BUSSE HOSPITAL DISPOSABLES, INC. 510(k) NO: K032432(TRADITIONAL)
ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320
P.O. BOX 2156 SE DECISION MADE: 28-AUG-03
HUNTINGTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFT-CELL DUAL LUMEN CATHETERS
C.R. BARD, INC. 510(k) NO: K030277(ABBREVIATED)
ATTN: GLENN NORTON PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 06-AUG-03
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BODYGUARD INFUSION SYSTEM
CAESAREA MEDICAL ELECTRONICS LTD. 510(k) NO: K031749(TRADITIONAL)
ATTN: GALI TZURY PHONE NO : 972 4 6271737
16 SHACHAM STREET SE DECISION MADE: 21-AUG-03
CAESAREA INDUSTRIAL PARK 510(k) STATEMENT
CAESAREA, ISRAEL 38900 THIRD PARTY REVIEW
DEVICE: DATACAPTOR
CAPSULE TECHNOLOGIE 510(k) NO: K032142(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 08-AUG-03
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMARC TISSUE MARKER
CARBON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K032347(SPECIAL)
ATTN: ROBERT W JOHNSON PHONE NO : 651-762-2146
1290 HAMMOND RD. SE DECISION MADE: 21-AUG-03
ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTIX/OR DEVICE
CARDIOSONIX, LTD. 510(k) NO: K030357(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 9 7670002
BEIT HAPA'AMON (BOX 124) SE DECISION MADE: 20-AUG-03
20 HATA'AS ST. 510(k) SUMMARY AVAILABLE FROM FDA
KFAR SABA, ISRAEL 44425
DEVICE: CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200
CARDIOVENTION, INC. 510(k) NO: K032068(TRADITIONAL)
ATTN: TESSA YAMUT PHONE NO : 408-844-5130
3045 STENDER WAY SE DECISION MADE: 22-AUG-03
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENTURION SES EPIKERATOME
CIBA VISION CORP. 510(k) NO: K031735(TRADITIONAL)
ATTN: PENNY NORTHCUTT PHONE NO : 678-415-3214
11460 JOHNS CREEK PKWY. SE DECISION MADE: 21-AUG-03
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION
CIBA VISION CORP. 510(k) NO: K031957(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 678-415-3897
11460 JOHNS CREEK PKWY. SE DECISION MADE: 14-AUG-03
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN C
CLINIQA CORPORATION 510(k) NO: K031577(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION RD. SE DECISION MADE: 06-AUG-03
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN
CLINIQA CORPORATION 510(k) NO: K031921(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-728-5205
1432-B SOUTH MISSION RD. SE DECISION MADE: 25-AUG-03
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: COLTOSOL F
COLTENE/WHALEDENT, INC. 510(k) NO: K031752(TRADITIONAL)
ATTN: H.J. VOGELSTEIN PHONE NO : 330-916-8800
235 ASCOT PKWY. SE DECISION MADE: 05-AUG-03
CUYAHOGA FALLS, OH 44223 510(k) STATEMENT
DEVICE: CADSTREAM
CONFIRMA, INC. 510(k) NO: K031779(TRADITIONAL)
ATTN: PATRICIA A MILBANK PHONE NO : 425-497-1700
821 KIRKLAND AVE. SE DECISION MADE: 06-AUG-03
KIRKLAND, WA 98033-6318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DBT, DYNAMIC BUBBLE TRAP
CONVERGENZA AG 510(k) NO: K031323(ABBREVIATED)
ATTN: CHRISTIE DEWITT PHONE NO : 239-992-3163
3625 WOODLAKE DR. SE DECISION MADE: 01-AUG-03
BONITA SPRINGS, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTO
COOK OB/GYN 510(k) NO: K030441(TRADITIONAL)
ATTN: BRENDA DAVIS PHONE NO : 812-829-6500
1100 W. MORGAN ST. SE DECISION MADE: 29-AUG-03
SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
CRYO VASCULAR SYSTEMS INC. 510(k) NO: K030742(TRADITIONAL)
ATTN: KIM TOMPKINS PHONE NO : 408-866-3203
160 KNOWLES DR. SE DECISION MADE: 29-AUG-03
LOS GATOS, CA 95032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOTRON 2 CRYOTHERAPY DEVICE
CRYONIC MEDICAL NORTH AMERICA 510(k) NO: K030281(TRADITIONAL)
ATTN: SANDRA WILLIAMSON PHONE NO : 610-470-7693
1350 DANIELSON RD. SE DECISION MADE: 20-AUG-03
MONTECITO, CA 93108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CERASORB ORTHO
CURASAN AG 510(k) NO: K031651(SPECIAL)
ATTN: ROLF KAUFMANN PHONE NO : 496 027 46860
LINDIGSTRASSE 4 SE DECISION MADE: 13-AUG-03
KLEINOSTHEIM, GERMANY 63801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N LATEX IGM
DADE BEHRING, INC. 510(k) NO: K032014(TRADITIONAL)
ATTN: KATHLEEN A DRAY-LYONS PHONE NO : 781-826-4551
GLASGOW SITE SE DECISION MADE: 07-AUG-03
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
DATASCOPE CORP. 510(k) NO: K031636(ABBREVIATED)
ATTN: SUSAN MANDY PHONE NO : 201-995-8025
800 MACARTHUR BLVD. SE DECISION MADE: 11-AUG-03
MAHWAH, NJ 07430-0619 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MATCH PRESS PRESSABLE CERAMIC
DAVIS SCHOTTLANDER & DAVIS, LTD. 510(k) NO: K024250(TRADITIONAL)
ATTN: CLYDE E INGERSOLL PHONE NO : 716-693-6591
54 RIVERVIEW AVE. SE DECISION MADE: 25-AUG-03
TONAWANDA, NY 14150-5260 510(k) STATEMENT
DEVICE: CARDIOQ, MODEL 9051-7005
DELTEX MEDICAL 510(k) NO: K031706(TRADITIONAL)
ATTN: LAWERENCE BROOKFIELD PHONE NO : 011 441 243523174
TERMINUS RD. SE DECISION MADE: 06-AUG-03
CHICHESTER, WEST SUSSEX, UNITED KI510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE
DENTAURUM 510(k) NO: K030977(TRADITIONAL)
ATTN: JAN W.A. DOORSCHODT PHONE NO : 215-968-2858
10 PHEASANT RUN SE DECISION MADE: 25-AUG-03
NEWTOWN, PA 18940 510(k) STATEMENT
DEVICE: DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE
DENTAURUM 510(k) NO: K030980(TRADITIONAL)
ATTN: JAN W.A. DOORSCHODT PHONE NO : 215-968-2858
10 PHEASANT RUN SE DECISION MADE: 25-AUG-03
NEWTOWN, PA 18940 510(k) STATEMENT
DEVICE: ANKYLOS
DENTSPLY CERAMCO 510(k) NO: K012681(TRADITIONAL)
ATTN: THOMAS B CAMERON PHONE NO : 800-487-0100
SIX TERRI LANE SE DECISION MADE: 22-AUG-03
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
BURLINGTON, NJ 08016
DEVICE: CARRIER TIPS
DENTSPLY INTL. 510(k) NO: K031461(TRADITIONAL)
ATTN: P. JEFFREY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE. SE DECISION MADE: 05-AUG-03
YORK, PA 17405-0872 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY ACE VERSANAIL TIBIAL NAIL
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K032097(SPECIAL)
ATTN: TIFFANI ROGERS PHONE NO : 574-371-4927
700 ORTHOPAEDIC DR. SE DECISION MADE: 08-AUG-03
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DEROYAL SURGICAL DRAPES BACKTABLE COVER
DEROYAL 510(k) NO: K030908(TRADITIONAL)
ATTN: AUDREY DANIELS PHONE NO : 865-362-7828
200 DEBUSK LN. SE DECISION MADE: 11-AUG-03
POWELL, TN 37849 510(k) STATEMENT
DEVICE: DESIGNS FOR VISION FIBEROPTIC LIGHT
DESIGNS FOR VISION, INC. 510(k) NO: K032283(SPECIAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 20-AUG-03
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT
DIAGNOSTICS BIOCHEM CANADA, INC. 510(k) NO: K030730(TRADITIONAL)
ATTN: G. R DUMONT PHONE NO : 519 681 8731
1020 HARGRIEVE RD. SE DECISION MADE: 18-AUG-03
LONDON, ONTARIO, CANADA N6E 1P5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)
DISCO-O-TECH MEDICAL TECHNOLOGIES,510(k) NO: K031401(TRADITIONAL)
ATTN: YAEL RUBIN PHONE NO : 972 995 11511
3 HASADNOAT ST. SE DECISION MADE: 06-AUG-03
HERZLIA, ISRAEL 46728 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DVNET MDV-PACS
DVNET INTERNATIONAL TECHNOLOGY CO.510(k) NO: K031816(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 424 635720
NO. 58, FU-CHIUN ST. SE DECISION MADE: 14-AUG-03
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT
DEVICE: EBI OMEGA21 SPINAL FIXATION SYSTEM
EBI, L.P. 510(k) NO: K031354(TRADITIONAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 06-AUG-03
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER
EBI, L.P. 510(k) NO: K032390(SPECIAL)
ATTN: BARRY SANDS PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 29-AUG-03
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICARION TO WACKERS-LIU CQ SOFTWARE
ECLIPSE SYSTEMS, INC. 510(k) NO: K032500(SPECIAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 25-AUG-03
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K032250(SPECIAL)
ATTN: SUSAN REYNOLDS PHONE NO : 949-250-2482
ONE EDWARDS WAY SE DECISION MADE: 26-AUG-03
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 46 CM (18.1") MONOCHROME LCD MONITOR, RADIFORCE G11; 53 CM (20.8
EIZO NANAO CORPORATION 510(k) NO: K032026(SPECIAL)
ATTN: KAY HAMAGUCHI PHONE NO : 815 963 71090
319 AKENO, OBATA-CHO SE DECISION MADE: 27-AUG-03
WATARAI-GUN, MIE-KEN, JAPAN 519-05510(k) STATEMENT
DEVICE: SPIDERVIEW
ELA MEDICAL, INC. 510(k) NO: K032466(SPECIAL)
ATTN: SUSAN OLIVE PHONE NO : 763-519-9400
2950 XENIUM LN. NORTH SE DECISION MADE: 22-AUG-03
SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55441
DEVICE: CRYOCARE CS SURGICAL SYSTEM
ENDOCARE, INC. 510(k) NO: K032333(TRADITIONAL)
ATTN: EBEN GORDON PHONE NO : 949-450-5424
201 TECHNOLOGY DR. SE DECISION MADE: 12-AUG-03
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EP-WORKMATE WITH RPM SYSTEM
EP MEDSYSTEMS 510(k) NO: K032225(SPECIAL)
ATTN: JAMES E KUHN PHONE NO : 856-753-8533
COOPER RUN EXECUTIVE PARK SE DECISION MADE: 20-AUG-03
575 ROUTE 73 N. BLDG. D 510(k) STATEMENT
WEST BERLIN, NJ 08091
DEVICE: VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
EPIMED INTERNATIONAL, INC. 510(k) NO: K023140(TRADITIONAL)
ATTN: CHRISTOPHER B LAKE PHONE NO : 518-725-0209
141 SAL LANDRIO DR. SE DECISION MADE: 15-AUG-03
CROSSROADS BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA
JOHNSTOWN, NY 12095
DEVICE: PRACTICEBUILDER 1-2-3
ERAD IMAGEMEDICAL CORP. 510(k) NO: K031778(TRADITIONAL)
ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648
16303 PANORAMIC WAY SE DECISION MADE: 07-AUG-03
SAN LEANDRO, CA 94578 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO E-SCAN XQ
ESAOTE S.P.A. 510(k) NO: K032121(SPECIAL)
ATTN: COLLEEN J DENSMORE PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE SE DECISION MADE: 13-AUG-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE POWERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
EST INTERNATIONAL CORPORATION 510(k) NO: K032236(TRADITIONAL)
ATTN: ELIZABETH DENG PHONE NO : 909-465-9188
7668 BELPINE PLACE SE DECISION MADE: 26-AUG-03
RANCHO CUCAMONGA, CA 91730 510(k) STATEMENT
DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
EST INTERNATIONAL CORPORATION 510(k) NO: K032272(TRADITIONAL)
ATTN: ELIZABETH DENG PHONE NO : 886-465-9188
7668 BELPINE PLACE SE DECISION MADE: 26-AUG-03
RANCHO CUCAMONGA, CA 91730 510(k) STATEMENT
DEVICE: CARDIOVATIONS PORTABLE VIDEO SYSTEM
ETHICON, INC. 510(k) NO: K032339(TRADITIONAL)
ATTN: PETER CECCHINI PHONE NO : 908-218-2457
ROUTE 22 WEST SE DECISION MADE: 08-AUG-03
SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION ORIA SPINAL SYSTEM
EUROSURGICAL S.A. 510(k) NO: K023884(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 304-598-0525
7000 HAMPTON CENTER SE DECISION MADE: 20-AUG-03
SUITE G1 510(k) SUMMARY AVAILABLE FROM FDA
MORGANTOWN, WV 26505
DEVICE: PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION
EV3 INC 510(k) NO: K032206(SPECIAL)
ATTN: GLEN D SMYTHE PHONE NO : 763-398-7391
4600 NATHAN LN. NORTH SE DECISION MADE: 08-AUG-03
PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONIK LDI 20 AIR
EVIT LABS, INC. 510(k) NO: K030374(TRADITIONAL)
ATTN: S. DAVID PIPER PHONE NO : 916-640-0485
4843 46TH STREET, BUILDING 351 SE DECISION MADE: 25-AUG-03
MCCLELLAN, CA 95652 510(k) STATEMENT
DEVICE: FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT
FCI OPHTHALMICS, INC. 510(k) NO: K023400(TRADITIONAL)
ATTN: HILLARD W WELCH PHONE NO : 508-775-5567
344 ANNABELLE POINT RD. SE DECISION MADE: 22-AUG-03
CENTERVILLE, MA 02632-2402 510(k) STATEMENT
DEVICE: SAFEPRO PLUS SAFETY SYRINGE
FORMOSA MEDICAL DEVICES, INC. 510(k) NO: K031830(TRADITIONAL)
ATTN: JOSEPH J CHANG PHONE NO : 832-545-8399
11497 COLUMBIA PARK DRIVE WEST SE DECISION MADE: 05-AUG-03
SUITE #9 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32258
DEVICE: MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEM
FRIADENT GMBH 510(k) NO: K031674(SPECIAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LN. SE DECISION MADE: 14-AUG-03
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIVE DENTAL IMPLANT SYSTEM MULTIPLE
FRIADENT GMBH 510(k) NO: K032158(SPECIAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LN. SE DECISION MADE: 14-AUG-03
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIVE TG DENTAL IMPLANT SYSTEM
FRIADENT GMBH 510(k) NO: K032284(SPECIAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LN. SE DECISION MADE: 14-AUG-03
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIVE 3.0 DENTAL IMPLANT SYSTEM
FRIANDENT GMBH 510(k) NO: K030639(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LN. SE DECISION MADE: 12-AUG-03
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNOVA 3100
GE MEDICAL SYSTEMS 510(k) NO: K031637(TRADITIONAL)
ATTN: LARRY KROGER PHONE NO : 262-544-3894
3000 N. GRANDVIEW BLVD, SE DECISION MADE: 22-AUG-03
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOSOFT/CASE CARDIAC TESTING SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K031561(TRADITIONAL)
ATTN: DAVID WAHLIG PHONE NO : 262-293-1705
8200 WEST TOWER AVE. SE DECISION MADE: 01-AUG-03
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 120 SERIES MATERNAL/FETAL MONITOR
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K032252(SPECIAL)
ATTN: MELISSA ROBINSON PHONE NO : 813-887-2133
4502 WOODLAND CORPORATE BLVD. SE DECISION MADE: 21-AUG-03
TAMPA, FL 33614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNITY NETWORK IS PATIENT VIEWER
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K032346(SPECIAL)
ATTN: DIANA M THORSON PHONE NO : 714-247-4135
8200 WEST TOWER AVE. SE DECISION MADE: 05-AUG-03
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: APEXPRO TELEMETRY SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K032369(SPECIAL)
ATTN: DIANA M THORSON PHONE NO : 714-247-4135
8200 WEST TOWER AVE. SE DECISION MADE: 15-AUG-03
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K032370(SPECIAL)
ATTN: KAREN M LUNDE PHONE NO : 414-362-3329
8200 WEST TOWER AVE. SE DECISION MADE: 13-AUG-03
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER
GLUSTITCH, INC. 510(k) NO: K030574(TRADITIONAL)
ATTN: DON BLACKLOCK PHONE NO : 800 667 2130
#307 7188 PROGRESS WAY SE DECISION MADE: 21-AUG-03
DELTA, B.C., CANADA V4G 1M6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESYNE SYSTEMS
GMP/COMPANIES, INC. 510(k) NO: K030795(TRADITIONAL)
ATTN: RALPH JUGO PHONE NO : 954-745-7694
ONE EAST BROWARD BLVD. SE DECISION MADE: 05-AUG-03
SUITE 1701 510(k) SUMMARY AVAILABLE FROM FDA
FORT LAUDERDALE, FL 33301
DEVICE: HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILI
GUIDANT CORP. 510(k) NO: K031678(TRADITIONAL)
ATTN: BRUCE CERWIN PHONE NO : 909-914-2676
26531 YNEZ RD. SE DECISION MADE: 26-AUG-03
TEMECULA, CA 92591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
HEMOCUE, INC. 510(k) NO: K032203(SPECIAL)
ATTN: R. J SLOMOFF PHONE NO : 301-893-1707
9229 CRANFORD DR. SE DECISION MADE: 25-AUG-03
POTOMAC, MD 20854 510(k) STATEMENT
DEVICE: V SET
HENNIG ENTERPRISES EUROPE S.R.L. 510(k) NO: K020424(TRADITIONAL)
ATTN: GEORGE O'NEIL PHONE NO : 61 8 93881700
25 SHANN ST., FLOREAT SE DECISION MADE: 29-AUG-03
PERTH, AUSTRALIA 6014 510(k) STATEMENT
DEVICE: ISOLETTE INFANT INCUBATOR, MODEL C2000E
HILL-ROM MANUFACTURING, INC. 510(k) NO: K031387(TRADITIONAL)
ATTN: MONICA FERRANTE PHONE NO : 215-682-8691
330 JACKSONVILLE RD. SE DECISION MADE: 01-AUG-03
HATBORO, PA 19040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K032503(SPECIAL)
ATTN: DOUG THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 22-AUG-03
TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II
HK SURGICAL, INC. 510(k) NO: K031432(ABBREVIATED)
ATTN: SALLY M BOWDON PHONE NO : 760-806-6543
2620A TEMPLE HEIGHTS DR. SE DECISION MADE: 07-AUG-03
OCEANSIDE, CA 92675 510(k) STATEMENT
DEVICE: GLUCOLEADER VALUE
HMD BIOMEDICAL, INC. 510(k) NO: K023279(TRADITIONAL)
ATTN: JEFFREY FLEISHMAN PHONE NO : 732-918-0770
3505 SUNSET AVE. SE DECISION MADE: 04-AUG-03
OCEAN, NJ 07712 510(k) STATEMENT
DEVICE: BONESOURCE BVF
HOWMEDICA OSTEONICS 510(k) NO: K031435(TRADITIONAL)
ATTN: DEBRA BING PHONE NO : 201-831-5413
59 ROUTE 17 SE DECISION MADE: 04-AUG-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFLEX ANTERIOR CERVICAL PLATE SYSTEM
HOWMEDICA OSTEONICS 510(k) NO: K031702(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
59 ROUTE 17 SE DECISION MADE: 08-AUG-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS SPINAL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K030369(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
59 ROUTE 17 SE DECISION MADE: 08-AUG-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER SPINE OASYS BONE SCREW
HOWMEDICA OSTEONICS CORP. 510(k) NO: K031657(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
59 ROUTE 17 SOUTH SE DECISION MADE: 22-AUG-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS
HOWMEDICA OSTEONICS CORP. 510(k) NO: K031730(SPECIAL)
ATTN: DEBRA BING PHONE NO : 201-831-5413
59 ROUTE 17 SE DECISION MADE: 29-AUG-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNIFIT HFX HIP STEM SERIES
HOWMEDICA OSTEONICS CORP. 510(k) NO: K031744(TRADITIONAL)
ATTN: DEBRA BING PHONE NO : 201-831-5413
59 ROUTE 17 SE DECISION MADE: 08-AUG-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAMMA 3 NAIL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K032244(SPECIAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
59 ROUTE 17 SOUTH SE DECISION MADE: 08-AUG-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K032264(SPECIAL)
ATTN: MARGARET F CROWE PHONE NO : 201-831-5580
59 ROUTE 17 SE DECISION MADE: 08-AUG-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S2 NAIL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K032579(SPECIAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
59 ROUTE 17 SE DECISION MADE: 29-AUG-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II
HYGIA HEALTH SERVICES, INC. 510(k) NO: K012715(TRADITIONAL)
ATTN: TRACY COMAS PHONE NO : 205-943-6670
2800 MILAN CT., SUITE 259 SE DECISION MADE: 01-AUG-03
BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IBL C1Q-CIC CIA TEST
IBL GMBH 510(k) NO: K032254(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 570-620-0198
150 CHERRY LANE RD. SE DECISION MADE: 29-AUG-03
EAST STROUDSBURG, PA 18301 510(k) STATEMENT
DEVICE: NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K031885(TRADITIONAL)
ATTN: DAVID M LEE PHONE NO : 321-309-8237
2290 EAU GALLIE BLVD. SE DECISION MADE: 21-AUG-03
MELBOURNE, FL 32935 510(k) STATEMENT
DEVICE: IMMUNICON CELLSAVE PRESERVATIVE TUBE
IMMUNICON CORP. 510(k) NO: K030596(TRADITIONAL)
ATTN: PETER SCOTT PHONE NO : 215-830-0777
3401 MASONS MILL RD. STE 100 SE DECISION MADE: 08-AUG-03
HUNTINGTON VALLEY, PA 19006-3574 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS
IMPLEX CORP. 510(k) NO: K031462(TRADITIONAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 06-AUG-03
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
IMPLEX CORP. 510(k) NO: K032282(SPECIAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 21-AUG-03
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX,
IMTEC CORP. 510(k) NO: K031106(TRADITIONAL)
ATTN: J. BRAD VANCE PHONE NO : 580-223-4456
2401 NORTH COMMERCE SE DECISION MADE: 12-AUG-03
ARDMORE, OK 73401 510(k) STATEMENT
DEVICE: INION OTPS BIODEGRADABLE PIN
INION LTD. 510(k) NO: K031712(TRADITIONAL)
ATTN: HANNA MARTTILA PHONE NO : 358 3 2306600
LAAKARINKATU 2 SE DECISION MADE: 28-AUG-03
TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)
INOVISE MEDICAL, INC. 510(k) NO: K030316(TRADITIONAL)
ATTN: KENDRA RATHKEY PHONE NO : 503-554-4277
1025 INDUSTRIAL PKWY. SE DECISION MADE: 07-AUG-03
SUITE C 510(k) SUMMARY AVAILABLE FROM FDA
NEWBERG, OR 97132 THIRD PARTY REVIEW
DEVICE: INTERMED ZOOM COLPOSCOPE
INTERMED GROUP, INC. 510(k) NO: K031639(TRADITIONAL)
ATTN: GEORGE GARAMY, JR. PHONE NO : 561-586-3667
3550 23RD AVE. SOUTH, SUITE #1 SE DECISION MADE: 22-AUG-03
LAKE WORTH, FL 33461 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERPORE CROSS CEMENT RESTRICTOR
INTERPORE CROSS INTL. 510(k) NO: K032095(SPECIAL)
ATTN: PROSIE REY-FESSLER PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 08-AUG-03
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K031692(TRADITIONAL)
ATTN: PAMELA MISAJON PHONE NO : 760-918-1820
6354 CORTE DEL ABETO SE DECISION MADE: 22-AUG-03
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009
DEVICE: IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS
IRIDEX CORP. 510(k) NO: K031665(TRADITIONAL)
ATTN: JOHN JOSSY PHONE NO : 650-962-8848
1212 TERRA BELLA AVE. SE DECISION MADE: 27-AUG-03
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTAPORT ZX
J. MORITA USA, INC. 510(k) NO: K031204(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070
1425 K ST. N.W. SE DECISION MADE: 21-AUG-03
11TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE
JDA (TIANJIN) PLASTIC RUBBER CO., 510(k) NO: K030529(TRADITIONAL)
ATTN: CHEN YUHONG PHONE NO : 861 065 666660-125
RM 707 AVIC BLDG.2 DONG SAN SE DECISION MADE: 08-AUG-03
HUAN NAN ROAD CHAOYANG DIST. 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING 100022, CHINA
DEVICE: JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE
JMS NORTH AMERICA CORP. 510(k) NO: K030479(TRADITIONAL)
ATTN: SWEE CHEAU PHONE NO : 510-888-9090
22320 FOOTHILL BLVD., SE DECISION MADE: 18-AUG-03
SUITE 350 510(k) STATEMENT
HAYWARD, CA 94541
DEVICE: HEATER COOLER UNIT, MODEL HCU 30
JOSTRA AB 510(k) NO: K031544(TRADITIONAL)
ATTN: LE ANN LATHAM PHONE NO : 281-363-4949
2828 N. CRESCENT RIDGE DR. SE DECISION MADE: 07-AUG-03
THE WOODLANDS, TX 77381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL TEMPERATURE MONITOR; MODEL KY-01
KANG YING MEDICAL APPLIANCES INC. 510(k) NO: K030219(TRADITIONAL)
ATTN: CHING-CHU CHEN PHONE NO : 585-869-6600
NO 25, TAI-L 1 ST., SE DECISION MADE: 05-AUG-03
JEN-TE HSIANG 510(k) SUMMARY AVAILABLE FROM FDA
TAINAN COUNTY, CHINA (TAIWAN)
DEVICE: KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT
KAPP SURGICAL INSTRUMENT, INC. 510(k) NO: K030237(TRADITIONAL)
ATTN: ALBERT SANTILLI PHONE NO : 216-587-4400
4919 WARRENSVILLE CENTER RD. SE DECISION MADE: 29-AUG-03
WARRENSVILLE HEIGHTS, OH 44128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KENTEX DISPOSABLE VAGINAL SPECULUM
KENTRON HEALTH CARE, INC. 510(k) NO: K030693(TRADITIONAL)
ATTN: DR. SADARANGANI PHONE NO : 615-384-0573
3604 KELTON JACKSON RD. SE DECISION MADE: 27-AUG-03
SPRINGFIELD, TN 37172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05
LEMAITRE VASCULAR, INC. 510(k) NO: K031282(TRADITIONAL)
ATTN: BRIAN K KEOGH PHONE NO : 781-221-2266
26 RAY AVE. SE DECISION MADE: 05-AUG-03
BURLINGTON, MA 01803 510(k) STATEMENT
DEVICE: DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
LEMAITRE VASCULAR, INC. 510(k) NO: K032041(TRADITIONAL)
ATTN: CARLOS CHAPARRO PHONE NO : 781-221-2266
63 2ND AVENUE SE DECISION MADE: 27-AUG-03
BURLINGTON, MA 01803 510(k) STATEMENT
DEVICE: ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS
LIFESCAN, INC. 510(k) NO: K031472(TRADITIONAL)
ATTN: FRANK PERALTA PHONE NO : 408-942-3588
1000 GIBRALTAR DR. SE DECISION MADE: 05-AUG-03
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINVATEC 300W XENON LIGHT SOURCE
LINVATEC CORP. 510(k) NO: K031994(TRADITIONAL)
ATTN: LAURA D KREJCI PHONE NO : 727-399-5234
11311 CONCEPT BLVD. SE DECISION MADE: 21-AUG-03
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO OUTBACK CATHETER
LUMEND, INC. 510(k) NO: K032298(SPECIAL)
ATTN: MICHAEL A DANIEL PHONE NO : 925-254-5228
400 CHESAPEAKE DR. SE DECISION MADE: 26-AUG-03
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM
LUXSANO AB 510(k) NO: K032191(SPECIAL)
ATTN: CONNIE HOY PHONE NO : 530-666-7616
908 STETSON STREET SE DECISION MADE: 20-AUG-03
WOODLAND, CA 95776 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OASYS-ORAL AIRWAY SYSTEM
MARK ABRAMSON, D.D.S., INC 510(k) NO: K030440(ABBREVIATED)
ATTN: MARK ABRAMSON PHONE NO : 650-369-9227
35 RENATO COURT SE DECISION MADE: 26-AUG-03
REDWOOD CITY, CA 94061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC
MED-TEC,INC. 510(k) NO: K031866(TRADITIONAL)
ATTN: DONALD F RIIBE PHONE NO : 712-737-8688
1401 8TH ST. S.E. SE DECISION MADE: 14-AUG-03
P.O. BOX 320 510(k) STATEMENT
ORANGE CITY, IA 51041
DEVICE: ISM1+, IMS2+, AND UTM+
MEDI-CULT A/S 510(k) NO: K030490(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751
P.O. BOX 262069 SE DECISION MADE: 20-AUG-03
SAN DIEGO, CA 92196-2069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K032335(TRADITIONAL)
ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891
5300 ADOLFO RD. SE DECISION MADE: 19-AUG-03
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: PBN GUIDEWIRES
MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K031442(TRADITIONAL)
ATTN: KARL SWARTZ PHONE NO : 352-338-0440
3600 S.W. 47TH AVE. SE DECISION MADE: 13-AUG-03
GAINESVILLE, FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SA 990 PLUS DIAGNOSTIC ULTRASOUND SYSTEM
MEDISON AMERICA, INC. 510(k) NO: K032329(TRADITIONAL)
ATTN: A. ROBERT DEPALMA PHONE NO : 714-889-3070
11075 KNOTT AVE. SE DECISION MADE: 06-AUG-03
CYPRESS, CA 90630 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MEDRAD MANUAL SYRINGE LOADER
MEDRAD, INC. 510(k) NO: K031483(TRADITIONAL)
ATTN: ANDREW P ZELTWANGER PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 01-AUG-03
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900
MEDSYS, S.A. 510(k) NO: K023735(ABBREVIATED)
ATTN: JEFF MORGAN PHONE NO : 253-535-9369
13723 DANA LN. EAST SE DECISION MADE: 07-AUG-03
PUYALLUP, WA 98373 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS
MEDTRADE PRODUCTS LTD. 510(k) NO: K022587(TRADITIONAL)
ATTN: JONATHAN D RANFIELD PHONE NO : 440 127 0500019
ELECTRA HOUSE SE DECISION MADE: 22-AUG-03
CREWE BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA
CREWE, CHESHIRE, UNITED KINGDOM CW1 6GL
DEVICE: MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S
MEDTRONIC MINIMED 510(k) NO: K031917(TRADITIONAL)
ATTN: MIRIELLE MENGOTTO PHONE NO : 818-576-4112
18000 DEVONSHIRE ST. SE DECISION MADE: 19-AUG-03
NORTHRIDGE, CA 91325-1219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332
MEDTRONIC MINIMED 510(k) NO: K032005(TRADITIONAL)
ATTN: MIRIELLE MENGOTTO PHONE NO : 818-576-4112
18000 DEVONSHIRE ST. SE DECISION MADE: 22-AUG-03
NORTHRIDGE, CA 91325-1219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K031700(TRADITIONAL)
ATTN: PREETI JAIN PHONE NO : 763-391-9000
7611 NORTHLAND DR. SE DECISION MADE: 29-AUG-03
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K032265(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 11-AUG-03
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STATCO2METER, MODEL 10-55372
MERCURY MEDICAL 510(k) NO: K031814(TRADITIONAL)
ATTN: WAYNE GLOVER PHONE NO : 727-573-0088
11300 49TH ST. NORTH SE DECISION MADE: 14-AUG-03
CLEARWATER, FL 33762-4800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOF
METRO OPTICS OF AUSTIN, INC. 510(k) NO: K031532(TRADITIONAL)
ATTN: DEANNA WERBER PHONE NO : 970-243-5490
623 GLACIER DR. SE DECISION MADE: 01-AUG-03
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONDUCTION CATHETER
MICOR, INC. 510(k) NO: K031600(TRADITIONAL)
ATTN: SUSAN FORGRAVE PHONE NO : 412-487-1113
2855 OXFORD BLVD. SE DECISION MADE: 13-AUG-03
ALLISON PARK, PA 15101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROPEAK
MICRO DIRECT, INC. 510(k) NO: K030586(TRADITIONAL)
ATTN: DAVID R STASZAK PHONE NO : 207-786-7808
803 WEBSTER ST. SE DECISION MADE: 27-AUG-03
LEWISTON, ME 04240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAPPHIRE DETACHABLE FIBER COILS
MICRO THERAPEUTICS, INC. 510(k) NO: K031852(TRADITIONAL)
ATTN: FLORIN TRUUVERT PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 20-AUG-03
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHELON MICRO CATHETER, MODEL 105-5091
MICRO THERAPEUTICS, INC. 510(k) NO: K031992(SPECIAL)
ATTN: MARILYN R POURAZAR PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 07-AUG-03
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRI METHADONE METABOLITE ENZYME IMMUNOASSAY
MICROGENICS CORP. 510(k) NO: K023617(TRADITIONAL)
ATTN: LAKSHMI ANNE PHONE NO : 510-979-5023
46360 FREMONT BLVD. SE DECISION MADE: 27-AUG-03
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JA1
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K031958(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 15-AUG-03
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR
MICRUS CORP. 510(k) NO: K031578(TRADITIONAL)
ATTN: MARGARET WEBBER PHONE NO : 408-830-5900
610 PALOMAR AVENUE SE DECISION MADE: 01-AUG-03
MOUNTAIN VIEW, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKS
MID-ATLANTIC DIAGNOSTICS, INC. 510(k) NO: K030525(TRADITIONAL)
ATTN: SUSAN J BUSH PHONE NO : 856-762-2000
438 NORTH ELMWOOD RD. SE DECISION MADE: 27-AUG-03
MARLTON, NJ 08053 510(k) STATEMENT
DEVICE: PERFECT CAPSULE
MILVELLA PTY. LTD. 510(k) NO: K030957(TRADITIONAL)
ATTN: JUDY F GORDON PHONE NO : 949-854-6314
2 DELPHINUS SE DECISION MADE: 20-AUG-03
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MITEK MICRO QUICKANCHOR
MITEK WORLDWIDE 510(k) NO: K032078(TRADITIONAL)
ATTN: SERGIO J GADALETA PHONE NO : 781-251-2918
A JOHNSON & JOHNSON COMPANY SE DECISION MADE: 25-AUG-03
249 VANDERBILT AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NORWOOD, MA 02062
DEVICE: ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
MONOBIND 510(k) NO: K030860(TRADITIONAL)
ATTN: JAY SINGH PHONE NO : 949-642-4830
729 WEST 16TH ST. SE DECISION MADE: 22-AUG-03
COSTA MESA, CA 92626 510(k) STATEMENT
DEVICE: NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8
MRI DEVICES CORP. 510(k) NO: K032090(SPECIAL)
ATTN: TOM SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 21-AUG-03
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: QSC-127 SHOULDER ARRAY COIL SET
MRI DEVICES CORP. 510(k) NO: K032429(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 21-AUG-03
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: NANMA ADJUSTABLE CONSTRICTION RING
NANMA MFG CO., LTD. 510(k) NO: K030119(TRADITIONAL)
ATTN: YOLANDA SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 06-AUG-03
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900
NEOGEN TECHNOLOGIES, INC 510(k) NO: K032301(TRADITIONAL)
ATTN: LYDIA B BIGGIE PHONE NO : 954-739-4972
5353 NW 35TH AVE. SE DECISION MADE: 21-AUG-03
FT LAUDERDALE, FL 33309 510(k) STATEMENT
DEVICE: HANDMASTER
NESS-NEUROMUSCULAR ELECTRICAL STIM510(k) NO: K031900(SPECIAL)
ATTN: JONATHAN KAHAN PHONE NO : 202-637-5794
555 13TH STREET, N.W. SE DECISION MADE: 08-AUG-03
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOLTOUCH INCORPORATED MODEL"CT3" ND:YAG SURGICAL LASER SYSTEMS
NEW STAR LASERS, INC. 510(k) NO: K031954(TRADITIONAL)
ATTN: DONALD V JOHNSON PHONE NO : 916-677-1912
9085 FOOTHILLS BLVD. SE DECISION MADE: 21-AUG-03
ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20
NIHON SEIMITSU SOKKI CO., LTD. 510(k) NO: K031582(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 01-AUG-03
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUASAR-QUASAR PLUS-QUASAR TORIC (HYBUFOCON A, HEXAFOCON A, PAFLU
NO 7 CONTACT LENS LABORATORY LTD. 510(k) NO: K032256(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 29-AUG-03
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOMOS CORVUS 5.0M
NOMOS CORP. 510(k) NO: K032209(SPECIAL)
ATTN: FRANCIS X DOBSCHA PHONE NO : 724-741-8242
200 WEST KENSINGER DR. SE DECISION MADE: 21-AUG-03
CRANBERRY TOWNSHIP, PA 16066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351; ET 400,
NORM PACIFIC AUTOMATION CORP. 510(k) NO: K031907(TRADITIONAL)
ATTN: CHI-CHU WU CHEN PHONE NO : 886 3 5785853
3F, NO. 31, HU-PIN ROAD #1 SE DECISION MADE: 21-AUG-03
SBIP 510(k) STATEMENT
HSIN-CHU, CHINA (TAIWAN)
DEVICE: CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165
NUCLEAR ASSOCIATES 510(k) NO: K030066(TRADITIONAL)
ATTN: CHRISTINE G CASTLEBERRY PHONE NO : 516-870-0100
120 ANDREWS RD. SE DECISION MADE: 29-AUG-03
HICKSVILLE, NY 11801 510(k) STATEMENT
DEVICE: SWIFT 2.0, MODEL 132.001
NUCLETRON CORP. 510(k) NO: K031158(SPECIAL)
ATTN: LISA DIMMICK PHONE NO : 410-312-4100
7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 07-AUG-03
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTP 1.2
NUCLETRON CORP. 510(k) NO: K031349(SPECIAL)
ATTN: LISA DIMMICK PHONE NO : 410-872-4435
7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 07-AUG-03
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007
NUCLETRON CORPORATION 510(k) NO: K032372(TRADITIONAL)
ATTN: LISA DIMMICK PHONE NO : 410-312-4100
7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 15-AUG-03
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DISPOSABLE N-PE MICKROKERATOME BLADES
OASIS MEDICAL, INC. 510(k) NO: K032297(SPECIAL)
ATTN: YVONNE FERNANDEZ PHONE NO : 909-305-5400
512 S. VERMONT AVE. SE DECISION MADE: 26-AUG-03
GLENDORA, CA 91740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS PREALBUMIN CALIBRATOR, ODR3029
OLYMPUS AMERICA, INC. 510(k) NO: K032285(ABBREVIATED)
ATTN: MICHAEL CAMPBELL PHONE NO : 972-556-9697
3131 WEST ROYAL LN. SE DECISION MADE: 21-AUG-03
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: ORTHOVIEW
OMSBAR LTD 510(k) NO: K032401(TRADITIONAL)
ATTN: ANTHONY THORNE PHONE NO : 011 44 1235817758
HAWKSWORTH SE DECISION MADE: 14-AUG-03
SOUTHMEAD INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
DIDCOT, OXFORDSHIRE, UNITED KINGDOTHIRD PARTY REVIEW
DEVICE: VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL R
ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K031924(TRADITIONAL)
ATTN: NEIL GREENBERG PHONE NO : 585-453-3768
100 INDIGO CREEK DR. SE DECISION MADE: 07-AUG-03
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CA
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K032296(SPECIAL)
ATTN: SUSAN WERNER PHONE NO : 585-453-4469
100 INDIGO CREEK DR. SE DECISION MADE: 13-AUG-03
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
ORTHOVITA, INC. 510(k) NO: K032409(TRADITIONAL)
ATTN: ANDREINA IDE PHONE NO : 610-407-5231
45 GREAT VALLEY PKWY. SE DECISION MADE: 29-AUG-03
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOMED SUBTALAR IMPLANT SYSTEM
OSTEOMED L.P. 510(k) NO: K031155(TRADITIONAL)
ATTN: DAWN T HOLDEMAN PHONE NO : 972-677-4600
3885 ARAPAHO RD. SE DECISION MADE: 22-AUG-03
ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V SET
P.T. GREENLEAF 510(k) NO: K020419(TRADITIONAL)
ATTN: GEORGE O'NEIL PHONE NO : 618 938 81700
25 SHANN ST., FLOREAT SE DECISION MADE: 29-AUG-03
PERTH, WESTERN AUSTRALIA, AUSTRALI510(k) STATEMENT
DEVICE: PEM 2400 PET SCANNER
PEM TECHNOLOGIES 510(k) NO: K032063(TRADITIONAL)
ATTN: IRVING WEINBERG PHONE NO : 301-315-2007
7617 STANDISH PLACE SE DECISION MADE: 18-AUG-03
ROCKVILLE, MD 20855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
PENTAX PRECISION INSTRUMENT CORP. 510(k) NO: K031789(TRADITIONAL)
ATTN: PAUL SILVA PHONE NO : 845-365-0700
30 RAMLAND RD. SE DECISION MADE: 08-AUG-03
ORANGEBURG, NY 10962 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM
PERCLOSE, INC. 510(k) NO: K031331(TRADITIONAL)
ATTN: JOANNA KUSKOWSKI PHONE NO : 650-474-3331
400 SAGINAW SE DECISION MADE: 12-AUG-03
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K031625(TRADITIONAL)
ATTN: JAMES F LOGAN PHONE NO : 410-837-1751
1301 DEFENCE HIGHWAY SE DECISION MADE: 01-AUG-03
GAMBRILLS, MD 21034 510(k) STATEMENT
DEVICE: BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHIT
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K031768(TRADITIONAL)
ATTN: JAMES F LOGAN PHONE NO : 410-837-1751
1301 DEFENCE HIGHWAY SE DECISION MADE: 01-AUG-03
GAMBRILLS, MD 21034 510(k) STATEMENT
DEVICE: HEARTSTART MRX, MODEL M3535A
PHILIPS MEDICAL SYSTEMS 510(k) NO: K031187(ABBREVIATED)
ATTN: PETER OHANIAN PHONE NO : 978-659-3397
3000 MINUTEMAN RD. SE DECISION MADE: 27-AUG-03
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS FRESCO RELEASE 1
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K031836(TRADITIONAL)
ATTN: LYNN T HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 14-AUG-03
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-3003
DEVICE: XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000
PHOTO MEDEX, INC. 510(k) NO: K031451(TRADITIONAL)
ATTN: BOB ROSE PHONE NO : 760-602-3300
2431 IMPALA DR. SE DECISION MADE: 01-AUG-03
CARLSBAD, CA 92008-7227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTE
PISHARODI SURGICALS, INC. 510(k) NO: K024313(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 29-AUG-03
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I
PLANAR SYSTEMS, INC. 510(k) NO: K032202(TRADITIONAL)
ATTN: SUSAN HAMANN PHONE NO : 781-895-1155
400 FIFTH AVENUE SE DECISION MADE: 01-AUG-03
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VKS/TC-PLUS REVISION KNEE
PLUS ORTHOPEDICS 510(k) NO: K032215(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 08-AUG-03
ROUND ROCK, TX 78681-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOGLOBIN A1C REAGENT SET
POINTE SCIENTIFIC, INC. 510(k) NO: K031539(TRADITIONAL)
ATTN: WILLIAM F WALTERS PHONE NO : 313-383-7220
1025 JOHN A. PAPALAS DR. SE DECISION MADE: 06-AUG-03
LINCOLN PARK, MI 48146 510(k) STATEMENT
DEVICE: PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE
PORTEX LTD. 510(k) NO: K030381(TRADITIONAL)
ATTN: STEVE OGILVIE PHONE NO : 440 130 3208011
MILITARY ROAD SE DECISION MADE: 27-AUG-03
HYTHE, KENT 510(k) SUMMARY AVAILABLE FROM FDA
ENGLAND CT21 6DB, UNITED KINGDOM
DEVICE: BIFURCATED ALLERGY SKIN TESTING NEEDLE
PRECISION MEDICAL PRODUCTS, INC. 510(k) NO: K031630(TRADITIONAL)
ATTN: RONALD D WOLFE PHONE NO : 717-335-3700
12 INDUSTRIAL WAY SE DECISION MADE: 07-AUG-03
DENVER, PA 17517 510(k) STATEMENT
DEVICE: EASY PULSE II OXYGEN CONSERVER
PRECISION MEDICAL, INC. 510(k) NO: K032018(TRADITIONAL)
ATTN: JAMES PARKER PHONE NO : 610-262-6090
300 HELD DR. SE DECISION MADE: 25-AUG-03
NORTHAMPTON, PA 18067 510(k) STATEMENT
DEVICE: PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES
PRECISION VASCULAR SYSTEMS, INC. 510(k) NO: K032146(ABBREVIATED)
ATTN: RICK GAYKOWSKI PHONE NO : 801-974-1736
2405 WEST ORTON CIR. SE DECISION MADE: 12-AUG-03
WEST VALLEY CITY, UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMSURE
PRODIGM, INC. 510(k) NO: K031975(TRADITIONAL)
ATTN: SUZANNE WILD PHONE NO : 530-897-0935
585 MANZANITA AVE., SUITE #1 SE DECISION MADE: 29-AUG-03
CHICO, CA 95926 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERI
PT. WRP BUANA MULTICORPORA 510(k) NO: K032010(TRADITIONAL)
ATTN: NG POY SIN PHONE NO : 061 694 2461
JALAN JERMAL #20B, KELURAHAN SE DECISION MADE: 19-AUG-03
SEI MATI, MEDAN LABUHAN KM 17 510(k) SUMMARY AVAILABLE FROM FDA
MEDAN, INDONESIA 20252
DEVICE: GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERI
PT. WRP BUANA MULTICORPORA 510(k) NO: K032011(TRADITIONAL)
ATTN: NG POY SIN PHONE NO : 061 694 2461
JALAN JERMAL #20B, KELURAHAN SE DECISION MADE: 19-AUG-03
SEI MATI, MEDAN LABUHAN KM 17 510(k) SUMMARY AVAILABLE FROM FDA
MEDAN, INDONESIA 20252
DEVICE: VIANOX DELIVERY SYSTEM, MODEL I
PULMONOX MEDICAL, INC. 510(k) NO: K023014(TRADITIONAL)
ATTN: PAULA TOMAT PHONE NO : 780 451 3660
10835-120TH ST. SE DECISION MADE: 14-AUG-03
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
EDMONTON, AB, CANADA T5H 3P9
DEVICE: EMBRACE WET-BOND RESTORATIVE MATERIAL
PULPDENT CORPORATION 510(k) NO: K031877(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND ST. SE DECISION MADE: 01-AUG-03
P.O. BOX 780 510(k) SUMMARY AVAILABLE FROM FDA
WATERTOWN, MA 02471-0780
DEVICE: PULPDENT ETCH-RITE ROYALE
PULPDENT CORPORATION 510(k) NO: K031915(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND ST. SE DECISION MADE: 05-AUG-03
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER
QINGDAO BESTEX RUBBER & PLASTIC PR510(k) NO: K031157(TRADITIONAL)
ATTN: ZECHUAN SHAO PHONE NO : 408-980-1348
2576 LAFAYETTE ST. SE DECISION MADE: 15-AUG-03
SANTA CLARA, CA 95050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R 72
RALCO S.R.L. 510(k) NO: K030487(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
333 MILFORD ROAD SE DECISION MADE: 01-AUG-03
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAMSOFT PACS, MODEL 3.0
RAMSOFT, INC. 510(k) NO: K031562(TRADITIONAL)
ATTN: LUCIAN POPESCU PHONE NO : 416 674 1347
215-16 FOUR SEASONS PLACE SE DECISION MADE: 11-AUG-03
TORONTO, ON, CANADA M9B 6E5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX LIQUID PROTEIN CALIBRATOR
RANDOX LABORATORIES, LTD. 510(k) NO: K031608(TRADITIONAL)
ATTN: P. ARMSTRONG PHONE NO : 44 289 4422413
ARDMORE, DIAMOND ROAD SE DECISION MADE: 08-AUG-03
CRUMLIN, CO. ANTRIM, UNITED KINGDO510(k) STATEMENT
DEVICE: CLICK HOLTER
REMCO ITALIA S.P.A. 510(k) NO: K032276(ABBREVIATED)
ATTN: LUIGI BUCCHI PHONE NO : 39 029 505181
VIA RIVOLTANA NUOVA 53 SE DECISION MADE: 27-AUG-03
SOUTH PEDRINO DI VIGNATE, MI., ITA510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VPAP III
RESMED LTD. 510(k) NO: K030843(TRADITIONAL)
ATTN: ROGER KOTTER PHONE NO : 858-746-2282
14040 DANIELSON ST. SE DECISION MADE: 15-AUG-03
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIRAGE VISTA MASK
RESMED LTD. 510(k) NO: K031047(TRADITIONAL)
ATTN: ROGER KOTTER PHONE NO : 858-746-2400
14040 DANIELSON ST. SE DECISION MADE: 19-AUG-03
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIODIRECT, MODELS 12M, 12I, 12S
REYNOLDS MEDICAL LTD. 510(k) NO: K024283(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 RT. 17 S. SE DECISION MADE: 01-AUG-03
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECYS SHBG CALCHECK
ROCHE DIAGNOSTICS CORP. 510(k) NO: K031698(TRADITIONAL)
ATTN: THERESA A AMBROSE PHONE NO : 317-521-3723
9115 HAGUE RD. SE DECISION MADE: 20-AUG-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS SHBG IMMUNOASSAY
ROCHE DIAGNOSTICS CORP. 510(k) NO: K031717(TRADITIONAL)
ATTN: THERESA M AMBROSE PHONE NO : 317-521-3723
9115 HAGUE RD. SE DECISION MADE: 05-AUG-03
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISET DAT PLUS I CALIBRATORS
ROCHE DIAGNOSTICS CORP. 510(k) NO: K031775(ABBREVIATED)
ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637
9115 HAGUE RD. SE DECISION MADE: 05-AUG-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISET TDM I AND PRECISET TDM II CALIBRATORS
ROCHE DIAGNOSTICS CORP. 510(k) NO: K031856(ABBREVIATED)
ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637
9115 HAGUE RD. SE DECISION MADE: 06-AUG-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS PRECICONTROL TROPONIN T
ROCHE DIAGNOSTICS CORP. 510(k) NO: K031990(TRADITIONAL)
ATTN: THERESA M AMBROSE PHONE NO : 317-521-3723
9115 HAGUE RD. SE DECISION MADE: 20-AUG-03
PO BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: ROCHE ONLINE TDM VALPROIC ACID
ROCHE DIAGNOSTICS CORP. 510(k) NO: K032049(TRADITIONAL)
ATTN: MIKE FLIS PHONE NO : 317-521-3080
P.O. BOX 50457 SE DECISION MADE: 22-AUG-03
9115 HAGUE RD. 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: TINA-QUANT CRP (LATEX)
ROCHE DIAGNOSTICS CORP. 510(k) NO: K032336(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 05-AUG-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
ROCHE DIAGNOSTICS CORP. 510(k) NO: K032377(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 21-AUG-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBRYON ULTRASOUND NEEDLE GUIDE
ROCKET MEDICAL PLC 510(k) NO: K032015(TRADITIONAL)
ATTN: TRACY CHARLTON PHONE NO : 440 191 4194488
WEAR INDUSTRIAL ESTATE SE DECISION MADE: 08-AUG-03
DISTRICT 6 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, TYNE & WEAR, UNITED KINGDOM NE38 9BZ
DEVICE: ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS
ROSTAM LTD. 510(k) NO: K032080(TRADITIONAL)
ATTN: ROBERT J STAAB PHONE NO : 201-327-0035
73 FRANKLIN TPK. SE DECISION MADE: 14-AUG-03
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S & C -BRACKET ADHESIVES
S & C POLYMER GMBH 510(k) NO: K031420(TRADITIONAL)
ATTN: CHRISTIAN BOETTTCHER PHONE NO : 49 412 14830
ROBERT-BOSCH-STRASSE 5 SE DECISION MADE: 20-AUG-03
ELMSHORN, GERMANY D-25335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SQUEEZE-EASE MAMMOGRAPHY CUSHION
S & S X-RAY PRODUCTS, INC. 510(k) NO: K031574(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD. SE DECISION MADE: 04-AUG-03
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226
SCHERING-PLOUGH HEALTHCARE PRODUCT510(k) NO: K031697(TRADITIONAL)
ATTN: PHILIP JOHNSON PHONE NO : 908-679-1959
3 CONNELL DR. SE DECISION MADE: 29-AUG-03
BERKELEY HEIGHTS, NJ 07922-0603 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HBS HEADLESS BONE SCREW
SCHOENING & ASSOC., INC. 510(k) NO: K030302(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LN. SE DECISION MADE: 08-AUG-03
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VI
SEAL POLYMER INDUSTRIES SDN. BHD. 510(k) NO: K032077(TRADITIONAL)
ATTN: CHUN CHOOI FONG PHONE NO : 605 322 3200
LOT 72706,JALAN LAHAT,KAWASAN SE DECISION MADE: 19-AUG-03
PERINDUSTRIAN BUKIT MERAH 510(k) SUMMARY AVAILABLE FROM FDA
LAHAT, PERAK, MALAYSIA 31500
DEVICE: APLAB, MODEL 801D0030
SECTOR MEDICAL CORP. 510(k) NO: K030379(TRADITIONAL)
ATTN: BRADLEY JEFFRIES PHONE NO : 770-975-1384
320 NORTHPOINT PKWY. SE DECISION MADE: 29-AUG-03
SUITE P 510(k) SUMMARY AVAILABLE FROM FDA
ACWORTH, GA 30102
DEVICE: LYRA NASAL MASK
SENSORMEDICS CORP. 510(k) NO: K031883(TRADITIONAL)
ATTN: PAUL L KITTINGER PHONE NO : 714-283-2228
22705 SAVI RANCH PKWY. SE DECISION MADE: 25-AUG-03
YORBA LINDA, CA 92887-4645 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE, POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH OR
SGMP CO., LTD. 510(k) NO: K032293(TRADITIONAL)
ATTN: JANNA TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 28-AUG-03
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE, POWDER FREE ORANGE LATEX EXAMINATION GLOVES W/ OR W
SGMP CO., LTD. 510(k) NO: K032294(TRADITIONAL)
ATTN: JANNA TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 28-AUG-03
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHIMADZU COLLIMATOR R-30H
SHIMADZU CORP. 510(k) NO: K031771(ABBREVIATED)
ATTN: TAKESHI OZAKI PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVE. SE DECISION MADE: 21-AUG-03
TORRANCE, CA 90502-1328 510(k) STATEMENT
DEVICE: SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K031433(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 19-AUG-03
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIROTORQUE L
SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K031584(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 19-AUG-03
NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SK MED M201 PLUS MIXER
SK MED 510(k) NO: K031707(SPECIAL)
ATTN: DIPAK GHOSH PHONE NO : 818-776-1325
16000 SHERMAN WAY #224 SE DECISION MADE: 01-AUG-03
VAN NUYS, CA 91406 510(k) STATEMENT
DEVICE: TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 721021
SMITH & NEPHEW, INC. 510(k) NO: K032197(SPECIAL)
ATTN: JASON BILOBRAM PHONE NO : 508-261-3699
130 FORBES BLVD. SE DECISION MADE: 08-AUG-03
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIORCI SCREW
SMITH & NEPHEW, INC. 510(k) NO: K032224(SPECIAL)
ATTN: MARION W GORDON PHONE NO : 978-749-1371
150 MINUTEMAN RD. SE DECISION MADE: 08-AUG-03
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT
SMITH & NEPHEW, INC. 510(k) NO: K032295(SPECIAL)
ATTN: JASON SELLS PHONE NO : 901-399-5520
1450 E. BROOKS RD. SE DECISION MADE: 21-AUG-03
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORRESTORE PATCH SYSTEM
SOMANETICS CORP. 510(k) NO: K031586(TRADITIONAL)
ATTN: RONALD A WIDMAN PHONE NO : 248-689-3050
1653 EAST MAPLE RD. SE DECISION MADE: 07-AUG-03
TROY, MI 48083-4208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310
SOTA PRECISION OPTICS, INC. 510(k) NO: K032341(ABBREVIATED)
ATTN: JAY MANSOUR PHONE NO : 770-777-4146
1308 MORNINGSIDE PARK DR. SE DECISION MADE: 25-AUG-03
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BENCO ADMIX
SOUTHERN DENTAL INDUSTRIES, INC. 510(k) NO: K032152(TRADITIONAL)
ATTN: SAMANTHA J CHEETHAM PHONE NO : 630-238-8300
729 N. ROUTE 83, SUITE 315 SE DECISION MADE: 06-AUG-03
BENSENVILLE, IL 60106 510(k) STATEMENT
DEVICE: TRAXIS CEMENT RESTRICTOR
SPINAL CONCEPTS, INC. 510(k) NO: K031318(SPECIAL)
ATTN: LISA PETERSON PHONE NO : 512-533-1080
5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 22-AUG-03
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINAL CONCEPTS, INC. INFIX SYSTEM
SPINAL CONCEPTS, INC. 510(k) NO: K031672(TRADITIONAL)
ATTN: LISA PETERSON PHONE NO : 512-533-1080
5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 07-AUG-03
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STARBOND DENTAL BONDING ALLOYS
STAR REFINING PRECIOUS METALS SOUT510(k) NO: K032106(TRADITIONAL)
ATTN: YOLANDA SMITH PHONE NO : 888-729-9674
PO BOX 4341 SE DECISION MADE: 25-AUG-03
CROFTON, MD 21114 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYST
STARPLEX SCIENTIFIC, INC. 510(k) NO: K032246(SPECIAL)
ATTN: MEHDI KARAMCHI PHONE NO : 416 674 7474
50 STEINWAY BLVD. SE DECISION MADE: 13-AUG-03
ETOBICOKE, ONTARIO, CANADA M9W 6Y3510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-11
STELLARTECH RESEARCH CORP. 510(k) NO: K032452(SPECIAL)
ATTN: JAMES R SANTOS PHONE NO : 408-331-3138
1346 BORDEAUX DR. SE DECISION MADE: 21-AUG-03
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOWIE-DICK MINI PAK, MODEL BD 115
STERITEC PRODUCTS, INC. 510(k) NO: K024293(ABBREVIATED)
ATTN: LINDA NELSON PHONE NO : 303-660-4201
599 TOPEKA WAY, SUITE 700 SE DECISION MADE: 11-AUG-03
CASTLE ROCK, CO 80109 510(k) STATEMENT
DEVICE: STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
STOCKERT INSTRUMENTE GMBH 510(k) NO: K032213(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN ST. SE DECISION MADE: 29-AUG-03
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL
STRAUMANN USA 510(k) NO: K032498(SPECIAL)
ATTN: LINDA JALBERT PHONE NO : 781-890-0001
RESERVOIR PLACE, SE DECISION MADE: 27-AUG-03
1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02451
DEVICE: STRYKER VISUM SURGICAL LIGHTING SYSTEM
STRYKER ENDOSCOPY 510(k) NO: K031068(TRADITIONAL)
ATTN: MELISSA MURPHY PHONE NO : 408-754-2148
5900 OPTICAL CT. SE DECISION MADE: 12-AUG-03
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER TOTAL PERFORMANCE (TPS) SYSTEM
STRYKER INSTRUMENTS 510(k) NO: K032117(SPECIAL)
ATTN: JEAN W SHEPPARD PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 08-AUG-03
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISUALINE METHADONE DIPSTRIPTEST
SUN BIOMEDICAL LABORATORIES, INC. 510(k) NO: K023856(TRADITIONAL)
ATTN: MING SUN PHONE NO : 856-401-1080
604 VPR CENTER SE DECISION MADE: 25-AUG-03
1001 LOWER LANDING RD. 510(k) SUMMARY AVAILABLE FROM FDA
BLACKWOOD, NJ 08012
DEVICE: PITANGA
SYNERON MEDICAL LTD. 510(k) NO: K031489(TRADITIONAL)
ATTN: AMIR WALDMAN PHONE NO : 972 67 404616
POB 550 SE DECISION MADE: 19-AUG-03
YOKNEAM ELITE, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AURORA DS
SYNERON MEDICAL LTD. 510(k) NO: K031988(SPECIAL)
ATTN: AMIR WALDMAN PHONE NO : 972 490 97424
APPOLO BLD., INDUSTRIAL ZONE SE DECISION MADE: 01-AUG-03
YOQNEQM ILLIT, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AURORA SR
SYNERON MEDICAL LTD. 510(k) NO: K031993(SPECIAL)
ATTN: AMIR WALDMAN PHONE NO : 972 490 97424
APPOLO BLD., INDUSTRIAL ZONE SE DECISION MADE: 01-AUG-03
YOQNEQM ILLIT, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVES
SYNMERTEX CO, LTD 510(k) NO: K032172(TRADITIONAL)
ATTN: ALBERT LING PHONE NO : 909-465-5769
1404 GREENPORT AVE. SE DECISION MADE: 14-AUG-03
ROWLAND HEIGHTS, CA 91748 510(k) STATEMENT
DEVICE: DISPOSABLE POWDERED VINYL EXAM GLOVES
SYNMERTEX CO, LTD 510(k) NO: K032190(TRADITIONAL)
ATTN: ALBERT LING PHONE NO : 909-465-5769
1404 GREENPORT AVE. SE DECISION MADE: 14-AUG-03
ROWLAND HEIGHTS, CA 91748 510(k) STATEMENT
DEVICE: SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE
SYNTHES (USA) 510(k) NO: K031428(TRADITIONAL)
ATTN: BONNIE J SMITH PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 08-AUG-03
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)
SYNTHES (USA) 510(k) NO: K031654(TRADITIONAL)
ATTN: BONNIE SMITH PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 08-AUG-03
POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYNTHES (USA) CALVICLE HOOK PLATE
SYNTHES (USA) 510(k) NO: K031677(TRADITIONAL)
ATTN: BONNIE J SMITH PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 21-AUG-03
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSO3 OZONE STERILIZER, MODEL 125L
TECHNOLOGIES OF STERILIZATION WITH510(k) NO: K020875(TRADITIONAL)
ATTN: CHARLES O HANCOCK PHONE NO : 716-223-1850
33 BLACK WATCH TRAIL SE DECISION MADE: 26-AUG-03
FAIRPORT, NY 14450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSO3 OZONE CHEMICAL INDICATOR
TECHNOLOGIES OF STERILIZATION WITH510(k) NO: K021161(TRADITIONAL)
ATTN: CHARLES O HANCOCK PHONE NO : 585-223-1850
33 BLACK WATCH TRAIL SE DECISION MADE: 27-AUG-03
FAIRPORT, NY 14450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERUMO AL8X ARTERIAL FILTER WITH X-COATING
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K032128(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL RD. SE DECISION MADE: 01-AUG-03
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO THERMACOOL TC SYSTEM
THERMAGE, INC. 510(k) NO: K032088(SPECIAL)
ATTN: PAMELA M BUCKMAN PHONE NO : 510-782-2286
4058 POINT EDEN WAY SE DECISION MADE: 01-AUG-03
HAYWARD, CA 94545-3721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TISSUELINK FLOATING BALL MODEL 23-201-1
TISSUELINK MEDICAL, INC. 510(k) NO: K032132(SPECIAL)
ATTN: VICKI ANASTASI PHONE NO : 603-742-1515
ONE WASHINGTON CENTER SE DECISION MADE: 20-AUG-03
SUITE #400 510(k) SUMMARY AVAILABLE FROM FDA
DOVER, NH 03820
DEVICE: SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K032281(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 06-AUG-03
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS M
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K032490(TRADITIONAL)
ATTN: MICHAELA MAHL PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 21-AUG-03
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VERSATREK
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K032306(SPECIAL)
ATTN: NADINE M SULLIVAN PHONE NO : 608-837-3788
982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 22-AUG-03
CLEVELAND, OH 44131 510(k) STATEMENT
DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K032382(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 440-250-1665
29299 CLEMENS RD. SUITE 1-K SE DECISION MADE: 29-AUG-03
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL
USA INSTRUMENTS, INC. 510(k) NO: K032415(SPECIAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000
1515 DANNER DR. SE DECISION MADE: 25-AUG-03
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL
USA INSTRUMENTS, INC. 510(k) NO: K032474(SPECIAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000
1515 DANNER DR. SE DECISION MADE: 25-AUG-03
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE
USGI MEDICAL, INC. 510(k) NO: K023902(TRADITIONAL)
ATTN: JUDY F GORDON PHONE NO : 949-854-6314
2 DELPHINUS SE DECISION MADE: 20-AUG-03
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM
VASCULAR ARCHITECTS, INC. 510(k) NO: K031641(TRADITIONAL)
ATTN: PHYLLIS ELSON PHONE NO : 408-392-7437
1830 BERING DR. SE DECISION MADE: 01-AUG-03
SAN JOSE, CA 95112-4226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PR
VASCULAR SOLUTIONS, INC. 510(k) NO: K032204(SPECIAL)
ATTN: DEBORAH JENSEN PHONE NO : 763-656-4349
6464 SYCAMORE COURT NORTH SE DECISION MADE: 20-AUG-03
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101
VELOCIMED 510(k) NO: K023548(TRADITIONAL)
ATTN: JOHN CARLINE PHONE NO : 763-463-4742
11400 73RD AVENUE NORTH SE DECISION MADE: 04-AUG-03
SUITE 134 510(k) SUMMARY AVAILABLE FROM FDA
MAPLE GROVE, MN 55369
DEVICE: IVENT 201 PORTABLE VENTILATOR
VERSAMED LTD. 510(k) NO: K021981(ABBREVIATED)
ATTN: KEN RAICHMAN PHONE NO : 972 989 97775
P.O.B. 5011, ORNAT BLDG. SE DECISION MADE: 13-AUG-03
HASHRON INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
KADIMA, ISRAEL 60920
DEVICE: BALL RECORDING ELECTRODE/STIMULATION PROBE
VIASYS HEALTHCARE, INC. 510(k) NO: K030517(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LN. SE DECISION MADE: 01-AUG-03
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACC
VIASYS HEALTHCARE, INC. 510(k) NO: K031713(TRADITIONAL)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LN. SE DECISION MADE: 12-AUG-03
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIATRONIX V3D EXPLORER, REVISION 1.2
VIATRONIX, INC. 510(k) NO: K032483(TRADITIONAL)
ATTN: MICHAEL MEISSNER PHONE NO : 631-444-9724
25 EAST LOOP RD., SUITE 204 SE DECISION MADE: 22-AUG-03
STONY BROOK, NY 11790 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM
VISION-SCIENCES, INC. 510(k) NO: K031786(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVE. SE DECISION MADE: 05-AUG-03
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1
VISTA SCIENTIFIC, LLC 510(k) NO: K024359(ABBREVIATED)
ATTN: JONATHAN MODINE PHONE NO : 303-652-1501
7960 NIWOT RD. SE DECISION MADE: 08-AUG-03
UNIT B-7 510(k) SUMMARY AVAILABLE FROM FDA
NIWOT, CO 80503
DEVICE: VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/
VITALCARE GROUP, INC. 510(k) NO: K031748(TRADITIONAL)
ATTN: MICHAEL MCAVENIA PHONE NO : 305-620-4007
8935 N.W. 27TH ST. SE DECISION MADE: 27-AUG-03
MIAMI, FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRI-LOOP MICROWAVE ABLATION PROBE
VIVANT MEDICAL, INC. 510(k) NO: K032047(SPECIAL)
ATTN: STEVEN KIM PHONE NO : 650-694-2900
1916-A OLD MIDDLEFIELD WAY SE DECISION MADE: 06-AUG-03
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLL
VYTERIS, INC. 510(k) NO: K031551(TRADITIONAL)
ATTN: GEORGE M BASKINGER PHONE NO : 201-703-2299
13-01 POLLITT DRIVE SE DECISION MADE: 20-AUG-03
FAIR LAWN, NJ 07410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
W. L. GORE & ASSOCIATES, INC. 510(k) NO: K032073(TRADITIONAL)
ATTN: BRANDON HANSEN PHONE NO : 928-864-3784
3450 WEST KILTIE LN. SE DECISION MADE: 13-AUG-03
FLAGSTAFF, AZ 86002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL
W. L. GORE & ASSOCIATES, INC. 510(k) NO: K032168(SPECIAL)
ATTN: BRANDON HANSEN PHONE NO : 928-864-3784
3450 WEST KILTIE LN. SE DECISION MADE: 15-AUG-03
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UROPOWER
W.O.M. WORLD OF MEDICINE AG 510(k) NO: K022721(TRADITIONAL)
ATTN: SUSANNE RAAB PHONE NO : 703-299-0523
368 NORTH ASAPH STREET SE DECISION MADE: 26-AUG-03
ALEXANDRIA, VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IUR FLUID MANAGEMENT SYSTEM
W.O.M. WORLD OF MEDICINE AG 510(k) NO: K031616(SPECIAL)
ATTN: SUSANNE RAAB PHONE NO : 703-299-0523
320 NORTH COLUMBUS ST. SE DECISION MADE: 13-AUG-03
ALEXANDRIA, VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LORENZ 2.4 SELF DRILLING SCREWS
WALTER LORENZ SURGICAL, INC. 510(k) NO: K032228(SPECIAL)
ATTN: KIM REED PHONE NO : 904-741-4400
1520 TRADEPORT DR. SE DECISION MADE: 11-AUG-03
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES
WELCH ALLYN PROTOCOL, INC. 510(k) NO: K031740(TRADITIONAL)
ATTN: JAMES W SANDBERG PHONE NO : 503-530-7339
8500 S.W. CREEKSIDE PLACE SE DECISION MADE: 26-AUG-03
BEAVERTON, OR 97008-7107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LED HEADLIGHT
WELCH ALLYN, INC. 510(k) NO: K031548(ABBREVIATED)
ATTN: DAVID KLEMENTOWSKI PHONE NO : 315-685-4133
4341 STATE ST. RD. SE DECISION MADE: 11-AUG-03
SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLID STATE LAMP [LED] HEADLIGHT
WELCH ALLYN, INC. 510(k) NO: K031549(ABBREVIATED)
ATTN: DAVID KLEMENTOWSKI PHONE NO : 315-685-4133
4341 STATE ST. RD. SE DECISION MADE: 11-AUG-03
SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNIPRO I'MRT
WELLHOFER DOSIMETRIE 510(k) NO: K031634(TRADITIONAL)
ATTN: THOMAS MATZEN PHONE NO : 46 18 180700
STALGATAN 14 SE DECISION MADE: 29-AUG-03
UPPSALA, SWEDEN 75450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOLVE CERAMIC RADIAL HEAD IMPLANT
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K030384(SPECIAL)
ATTN: JEANINE H REDDEN PHONE NO : 901-867-4522
5677 AIRLINE RD. SE DECISION MADE: 12-AUG-03
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WIT
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K032464(SPECIAL)
ATTN: TERENCE LIM PHONE NO : 603 870 61486
LOT 1, JALAN 3, SE DECISION MADE: 22-AUG-03
KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA
SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900
DEVICE: ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NA
ZIMMER, INC. 510(k) NO: K032367(SPECIAL)
ATTN: STEPHEN H MCKELVEY PHONE NO : 574-372-4944
P.O. BOX 708 SE DECISION MADE: 12-AUG-03
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 321
TOTAL WITH SUMMARIES 261
TOTAL WITH STATEMENTS 60
Updated September 5, 2003
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