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510(k)s Final Decisions Rendered for August 2003 |
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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