-
Medical Devices
-
August 2003 510(k) Clearances
Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance.
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 TEC 510(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 PRODUCT 510(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
-
-