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510(k)s Final Decisions Rendered for March 2004 |
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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-MAR-2004 THROUGH 31-MAR-2004
DEVICE: A&D; MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB
A & D ENGINEERING, INC. 510(k) NO: K040229(SPECIAL)
ATTN: JERRY WANG PHONE NO : 408-518-5113
1555 MC CANDLESS DR. SE DECISION MADE: 19-MAR-04
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTINUM
AALBA DENT, INC. 510(k) NO: K040179(TRADITIONAL)
ATTN: VINCENT M BENETTI PHONE NO : 707-864-3334
400 WATT DR. SE DECISION MADE: 03-MAR-04
CORDELIA, CA 94534 510(k) STATEMENT
DEVICE: CONTINUM V
AALBA DENT, INC. 510(k) NO: K040180(TRADITIONAL)
ATTN: VINCENT M BENETTI PHONE NO : 707-864-3334
400 WATT DR. SE DECISION MADE: 04-MAR-04
CORDELIA, CA 94534 510(k) STATEMENT
DEVICE: PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
ABBOTT LABORATORIES 510(k) NO: K040628(SPECIAL)
ATTN: GRAHAM BAILLIE PHONE NO : 781-276-6389
4-A CROSBY DR. SE DECISION MADE: 25-MAR-04
BEDFORD, MA 01730-1402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCULASER PRO4
ACCULASER, INC. 510(k) NO: K023060(TRADITIONAL)
ATTN: PATSY J TRISLER PHONE NO : 301-652-5344
5610 WISCONSIN AVENUE #304 SE DECISION MADE: 19-MAR-04
CHEVY CHASE, MD 20815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RFS VACUUM GAUGE SCAVENGING CIRCUIT
ACCUTRON, INC. 510(k) NO: K033503(SPECIAL)
ATTN: ROBERT N CLARK PHONE NO : 303-234-9412
13605 WEST 7TH AVENUE SE DECISION MADE: 12-MAR-04
GOLDEN, CO 80401-4604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSAB
ACIST MEDICAL SYSTEMS, INC. 510(k) NO: K040298(SPECIAL)
ATTN: CARL M BEAURLINE PHONE NO : 952-995-9319
7450 FLYING CLOUDS DR. SE DECISION MADE: 15-MAR-04
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
EDEN PRAIRIE, MN 55344
DEVICE: LACRYTEST
ADIATEC SA 510(k) NO: K034057(TRADITIONAL)
ATTN: JOEL LESSER PHONE NO : 332 517 21140
5 PASSAGE DOUARD SE DECISION MADE: 09-MAR-04
4 RUE DES OLIVETTES 510(k) SUMMARY AVAILABLE FROM FDA
NANTES, FRANCE 44000
DEVICE: ART POSTERIOR SPINAL SYSTEM
ADVANCED MEDICAL TECHNOLOGIES AG 510(k) NO: K033150(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 01-MAR-04
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPID PROGRAMMER
ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K040609(SPECIAL)
ATTN: RASHMI MOZA PHONE NO : 972-309-8055
6501 WINDCREST DRIVE SUITE 100 SE DECISION MADE: 25-MAR-04
PLANO, TX 75024 510(k) STATEMENT
DEVICE: AESCULAP ABSORBABLE CRANIOFIX
AESCULAP, INC. 510(k) NO: K040080(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 31-MAR-04
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SON
ALOKA CO., LTD. 510(k) NO: K040719(TRADITIONAL)
ATTN: RICHARD J CEHOVSKY PHONE NO : 203-269-5088
10 FAIRFIELD BLVD. SE DECISION MADE: 26-MAR-04
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ICON POLYAXIAL PEDICLE SCREW SYSTEM
ALPHATEC MFG., INC. 510(k) NO: K033090(TRADITIONAL)
ATTN: ELLEN A HICKS PHONE NO : 760-431-9132
6110 CORTE DEL CEDRO SE DECISION MADE: 26-MAR-04
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE
AMBU, INC. 510(k) NO: K032278(TRADITIONAL)
ATTN: SANJAY PARIKH PHONE NO : 410-636-1144
611 NORTH HAMMONDS FERRY RD. SE DECISION MADE: 05-MAR-04
LINTHICUM, MD 21090-1356 510(k) STATEMENT
DEVICE: AMEDITECH IMMU TEST DRUG SCREEN PANEL
AMEDITECH, INC. 510(k) NO: K040092(SPECIAL)
ATTN: JOHN WU PHONE NO : 858-535-1968
10340 CAMINO SANTA FE, SUITE F SE DECISION MADE: 08-MAR-04
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K040521(SPECIAL)
ATTN: ELSA A LINKE PHONE NO : 952-930-6000
10700 BREN RD., WEST SE DECISION MADE: 24-MAR-04
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K040538(SPECIAL)
ATTN: DENISE THOMPSON PHONE NO : 952-930-6489
10700 BREN RD., WEST SE DECISION MADE: 17-MAR-04
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QONTRAST
AMID 510(k) NO: K040399(TRADITIONAL)
ATTN: COLLEEN DENSMORE PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE SE DECISION MADE: 29-MAR-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
ANGIODYNAMICS, INC. 510(k) NO: K040446(SPECIAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 05-MAR-04
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: ANSON REFIX VASCULAR AND TISSUE CLIP, MODELS GF-04-01 AND GF-04-
ANSON MEDICAL LTD. 510(k) NO: K032896(TRADITIONAL)
ATTN: IAN QUIRK PHONE NO : 011 44 1235862122
67 MILTON PARK SE DECISION MADE: 17-MAR-04
ABINGDON, UNITED KINGDOM OX14 4RX 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED LATEX EXAMINATION GLOVES
APL INTERNATIONAL INCORPORATED LIM510(k) NO: K033531(TRADITIONAL)
ATTN: LEE SON HONG PHONE NO : 008 461 543298
LONG THANH DISTRICT SE DECISION MADE: 03-MAR-04
DONG NAU PROVINCE 510(k) STATEMENT
DONG NAU, VIETNAM
DEVICE: LED TURBO
APOZA ENTERPRISE CO. LTD. 510(k) NO: K040618(TRADITIONAL)
ATTN: SHIH MIN-TEH PHONE NO : 886 2 29010620
6 F,NO. 657, CHUNG-CHENG ROAD SE DECISION MADE: 25-MAR-04
HSIN-CHUANG CITY 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI HSIEN, CHINA (TAIWAN) 242
DEVICE: ARIOL
APPLIED IMAGING CORP. 510(k) NO: K033200(TRADITIONAL)
ATTN: DIANE OATES PHONE NO : 408-450-4304
2380 WALSH AVE., BLDG.B SE DECISION MADE: 18-MAR-04
SANTA CLARA, CA 95051 510(k) STATEMENT
DEVICE: APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K040295(TRADITIONAL)
ATTN: CHERYL BLAKE PHONE NO : 949-713-8327
22872 AVENIDA EMPRESSA SE DECISION MADE: 12-MAR-04
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INTEGRAL HEMODIALYSIS CATHETER
ARROW INT'L. 510(k) NO: K040260(SPECIAL)
ATTN: BRANDON EPTING PHONE NO : 610-378-0131
2400 BERNVILLE RD. SE DECISION MADE: 05-MAR-04
READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARROW ECHOGENIC INTRODUCER NEEDLE
ARROW INTL., INC. 510(k) NO: K040100(TRADITIONAL)
ATTN: WILLIAM G MCLAIN PHONE NO : 610-378-0131
2400 BERNVILLE RD. SE DECISION MADE: 01-MAR-04
P.O. BOX 12888 510(k) SUMMARY AVAILABLE FROM FDA
READING, PA 19605
DEVICE: ARTHROCARE CONTROLLER, CABLE, FOOT CONTROL, POWER CORD, WANDS, M
ARTHROCARE CORP. 510(k) NO: K040338(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 01-MAR-04
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APM BLOOD PRESSURE MONITOR, MODEL BP108A
ASIA PACIFIC MICROSYSTEMS, INC. 510(k) NO: K040159(ABBREVIATED)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 22-MAR-04
HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRION MEDICAL QL INFLATION DEVICE
ATRION MEDICAL PRODUCTS, INC. 510(k) NO: K032840(TRADITIONAL)
ATTN: DAN CLARK PHONE NO : 256-586-1580
1426 CURT FRANCIS RD. SE DECISION MADE: 03-MAR-04
ARAB, AL 35016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B.BRAUN PREMIXED DIALYSATE
B. BRAUN MEDICAL, INC. 510(k) NO: K034066(TRADITIONAL)
ATTN: PATRICIA D WILSON PHONE NO : 610-266-0500
901 MARCON BLVD. SE DECISION MADE: 03-MAR-04
ALLENTOWN, PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM
BARCO NV 510(k) NO: K040039(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE, # 931 SE DECISION MADE: 17-MAR-04
ALBUQUERQUE, NM 87111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM
BARCO NV BARCOVIEW 510(k) NO: K040040(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE SE DECISION MADE: 29-MAR-04
# 931 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87111
DEVICE: NIO 3MP MEDICAL GRAYSCALE DISPLAY SYSTEM
BARCO NV BARCOVIEW 510(k) NO: K040041(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE SE DECISION MADE: 29-MAR-04
# 931 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87111
DEVICE: ZYOPTIX XP MICROKERATOME
BAUSCH & LOMB, INC. 510(k) NO: K040204(SPECIAL)
ATTN: DEBRA L.B. KETCHUM PHONE NO : 585-338-8638
1400 NORTH GOODMAN ST. SE DECISION MADE: 22-MAR-04
ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS DHEA-S REAGENT ASSAY
BECKMAN COULTER, INC. 510(k) NO: K040181(ABBREVIATED)
ATTN: MARY BETH TANG PHONE NO : 714-961-3777
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 24-MAR-04
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG
BECTON, DICKINSON AND COMPANY 510(k) NO: K032675(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 01-MAR-04
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY
BECTON, DICKINSON AND COMPANY 510(k) NO: K033861(TRADITIONAL)
ATTN: COLLEEN A KISTLER PHONE NO : 410-316-4988
7 LOVETON CIR. SE DECISION MADE: 09-MAR-04
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
BECTON, DICKINSON AND COMPANY 510(k) NO: K040099(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 19-MAR-04
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM P
BECTON, DICKINSON AND COMPANY 510(k) NO: K040106(TRADITIONAL)
ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778
7 LOVETON CIR. SE DECISION MADE: 11-MAR-04
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY
BERKELEY ADVANCED BIOMATERIALS, IN510(k) NO: K040405(SPECIAL)
ATTN: FRANCOIS GENIN PHONE NO : 510-883-1644
1933 DAVIS ST. SUITE 307 SE DECISION MADE: 05-MAR-04
SAN LEANDRO, CA 94577 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM)
BIO-LOK INTL., INC. 510(k) NO: K032454(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 04-MAR-04
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYPHOCHEK ASSAYED CHEMISTRY CONTROL
BIO-RAD LABORATORIES, INC. 510(k) NO: K040273(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 04-MAR-04
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK CARDIAC MARKER CONTROL LT
BIO-RAD LABORATORIES, INC. 510(k) NO: K040277(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367
9500 JERONIMO RD. SE DECISION MADE: 10-MAR-04
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BILOK ST SCREW
BIOCOMPOSITES LTD. 510(k) NO: K033792(TRADITIONAL)
ATTN: J. STEPHEN BRATT PHONE NO : 44 178 2206500
ETRUSCAN ST., ETRURIA SE DECISION MADE: 01-MAR-04
STOKE ON TRENT, UNITED KINGDOM ST1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50
BIOLITEC, INC. 510(k) NO: K032863(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST., NW SE DECISION MADE: 19-MAR-04
WASHINGTON, DC 20004-5910 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERALAS D 810 DIODE LASER SYSTEM, MODEL D15
BIOLITEC, INC. 510(k) NO: K032864(TRADITIONAL)
ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794
555 THIRTEENTH ST., NW SE DECISION MADE: 19-MAR-04
WASHINGTON, DC 20004-5910 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIGH VOLTAGE PULSED STIMULATOR, MODEL "BMLS02-7"
BIOMEDICAL LIFE SYSTEMS, INC. 510(k) NO: K040306(TRADITIONAL)
ATTN: GARY BUSSETT PHONE NO : 760-727-5600
P.O. BOX 1360 SE DECISION MADE: 23-MAR-04
VISTA, CA 92085-1360 510(k) STATEMENT
DEVICE: BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX
BIOTEQUE CORP. 510(k) NO: K032292(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 22-MAR-04
FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIRD TBIRD VELA VENTILATOR
BIRD PRODUCTS CORP. 510(k) NO: K032451(TRADITIONAL)
ATTN: TOM GUTIERREZ PHONE NO : 760-778-7255
1100 BIRD CENTER DR. SE DECISION MADE: 17-MAR-04
PALM SPRINGS, CA 92262 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS
BISCO, INC. 510(k) NO: K034024(TRADITIONAL)
ATTN: BENJAMIN LICHTENWALNER PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 19-MAR-04
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
BLACKSTONE MEDICAL, INC. 510(k) NO: K033702(TRADITIONAL)
ATTN: DEAN E CIPORKIN PHONE NO : 413-726-2513
90 BROOKSDALE DR. SE DECISION MADE: 31-MAR-04
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION)
BLACKSTONE MEDICAL, INC. 510(k) NO: K033980(SPECIAL)
ATTN: DEAN E CIPORKIN PHONE NO : 413-726-2513
90 BROOKSDALE DR. SE DECISION MADE: 03-MAR-04
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR SE MICROSPHERES
BOSTON SCIENTIFIC CORP. 510(k) NO: K034068(TRADITIONAL)
ATTN: JENNIFER BOLTON PHONE NO : 508-652-5972
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 26-MAR-04
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087,
BOSTON SCIENTIFIC CORP. 510(k) NO: K040447(SPECIAL)
ATTN: JAMES D MCMAHON PHONE NO : 508-650-8000
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 12-MAR-04
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER
BOSTON SCIENTIFIC CORP. 510(k) NO: K040492(TRADITIONAL)
ATTN: NICHOLAS CONDAKES PHONE NO : 508-652-5003
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 16-MAR-04
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM
BOSTONSCIENTIFIC 510(k) NO: K040027(TRADITIONAL)
ATTN: CANDICE R BURNS PHONE NO : 763-494-2845
ONE SCIMED PLACE SE DECISION MADE: 30-MAR-04
MAPLE GROVE, MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN
BRAHMS DIAGNOSTICA, LLC. 510(k) NO: K033454(TRADITIONAL)
ATTN: WILLIAM G FRANK PHONE NO : 770-449-7738
35-B SOUTH PEACHTREE ST. SE DECISION MADE: 22-MAR-04
NORCROSS, GA 30071 510(k) STATEMENT
DEVICE: MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II
BRANAN MEDICAL CORP. 510(k) NO: K040203(TRADITIONAL)
ATTN: RAPHAEL WONG PHONE NO : 949-598-7166
10015 MUIRLANDS RD., SUITE E SE DECISION MADE: 25-MAR-04
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: CORLINK AUTOMATED ANASTOMOTIC SYSTEM
BY-PASS MAKAFIM LTD. 510(k) NO: K033979(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 13TH ST. NW SE DECISION MADE: 31-MAR-04
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERPICC CATHETERS, MODELS 3175155, 3175135
C.R. BARD, INC. 510(k) NO: K033389(TRADITIONAL)
ATTN: MICHAELA RIVKOWICH PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 19-MAR-04
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 01170
C.R. BARD, INC. 510(k) NO: K033814(TRADITIONAL)
ATTN: SUZANNE LASCALZA PHONE NO : 401-463-7000
100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 01-MAR-04
P.O. BOX 8500 510(k) SUMMARY AVAILABLE FROM FDA
CRANSTON, RI 02920
DEVICE: NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM
CENTERPULSE ORTHOPEDICS, INC. 510(k) NO: K033810(TRADITIONAL)
ATTN: AUDREY SWEARINGEN PHONE NO : 512-432-9255
9900 SPECTRUM DR. SE DECISION MADE: 05-MAR-04
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNESYS SPINAL SYSTEM
CENTERPULSE SPINE-TECH, INC. 510(k) NO: K031511(TRADITIONAL)
ATTN: ANGELA BYLAND PHONE NO : 952-857-5631
7375 BUSH LAKE RD. SE DECISION MADE: 05-MAR-04
MINNEAPOLIS, MN 55439-2027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TOR
CIBA VISION CORPORATION 510(k) NO: K033919(TRADITIONAL)
ATTN: ALICIA M PLESNARSKI PHONE NO : 678-415-3924
11440 JOHNS CREEK PKWY. SE DECISION MADE: 12-MAR-04
DULUTH, GA 30097-1556 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR
CLINICAL DATA, INC. 510(k) NO: K034000(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 WEST LAMBERT ROAD SE DECISION MADE: 10-MAR-04
BREA, CA 92821-2944 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VITALAB URIC ACID REAGENT
CLINICAL DATA, INC. 510(k) NO: K040467(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 W. LAMBERT ROAD SE DECISION MADE: 08-MAR-04
SUITE D 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92821 THIRD PARTY REVIEW
DEVICE: VITALAB MAGNESIUM REAGENT
CLINICAL DATA, INC. 510(k) NO: K040508(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 W. LAMBERT ROAD SE DECISION MADE: 08-MAR-04
SUITE D 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92821 THIRD PARTY REVIEW
DEVICE: VITALAB AMYLASE REAGENT
CLINICAL DATA, INC. 510(k) NO: K040534(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 WEST LAMBERT ROAD SE DECISION MADE: 11-MAR-04
BREA, CA 92821-2944 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VITALAB DIRECT BILIRUBIN REAGENT
CLINICAL DATA, INC. 510(k) NO: K040631(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 WEST LAMBERT ROAD SE DECISION MADE: 18-MAR-04
BREA, CA 92821-2944 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS
CLINIQA CORPORATION 510(k) NO: K040455(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION RD. SE DECISION MADE: 05-MAR-04
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COUL
CLINIQA CORPORATION 510(k) NO: K040535(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION RD. SE DECISION MADE: 29-MAR-04
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: IV ADMINISTRATION AND CONNECT SETS
CODAN US CORP. 510(k) NO: K033301(TRADITIONAL)
ATTN: ROHIT PATEL PHONE NO : 714-545-2111
3511 WEST SUNFLOWER AVE. SE DECISION MADE: 04-MAR-04
SANTA ANA, CA 92704-6944 510(k) STATEMENT
DEVICE: COLLAGEN DENTAL WOUND DRESSINGS
COLLAGEN MATRIX, INC. 510(k) NO: K033729(TRADITIONAL)
ATTN: PEGGY HANSEN PHONE NO : 201-405-1477
509 COMMERCE ST. SE DECISION MADE: 17-MAR-04
FRANKLIN LAKES,, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
COLLAGEN MATRIX, INC. 510(k) NO: K040558(SPECIAL)
ATTN: PEGGY HANSEN PHONE NO : 201-405-1477
509 COMMERCE ST. SE DECISION MADE: 17-MAR-04
FRANKLIN LAKES,, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLTOLUX LED CURING LIGHT
COLTENE/WHALEDENT INC. 510(k) NO: K040551(TRADITIONAL)
ATTN: H.J. VOGELSTEIN PHONE NO : 212-289-4748
1349 LEXINGTON AVE. SE DECISION MADE: 15-MAR-04
NEW YORK, NY 10128 510(k) STATEMENT
DEVICE: OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
CONTAMAC LTD. 510(k) NO: K033594(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DR. SE DECISION MADE: 19-MAR-04
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYDNEY IVF PVP
COOK UROLOGICAL, INC. 510(k) NO: K031304(TRADITIONAL)
ATTN: BRENDA DAVIS PHONE NO : 812-829-6500
1100 WEST MORGAN ST. SE DECISION MADE: 23-MAR-04
P.O. BOX 227 510(k) SUMMARY AVAILABLE FROM FDA
SPENCER, IN 47460
DEVICE: ZILVER 635 BILIARY STENT
COOK, INC. 510(k) NO: K040505(SPECIAL)
ATTN: LELAND KEYT PHONE NO : 812-339-2235
750 DANIELS WAY PO BX 489 SE DECISION MADE: 16-MAR-04
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B;
CORDIS CORPORATION 510(k) NO: K034050(TRADITIONAL)
ATTN: DONNA MARSHALL PHONE NO : 908-412-3844
7 POWDER HORN DRIVE SE DECISION MADE: 22-MAR-04
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERASORB M ORTHO
CURASAN AG 510(k) NO: K040216(SPECIAL)
ATTN: ERIC WIECHERT PHONE NO : 919-772-8518
109 SHORE DRIVE SE DECISION MADE: 26-MAR-04
GARNER, NC 27529 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 10
CUSTOM PLASTIC PRODUCTS 510(k) NO: K033518(TRADITIONAL)
ATTN: JIM BARLEY PHONE NO : 949-364-9349
28481 LA FALDA SE DECISION MADE: 10-MAR-04
LAGUNA NIGUEL, CA 92677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IFL PROFESSIONAL SYSTEM, MODEL C100
CYDEN LIMITED 510(k) NO: K040156(TRADITIONAL)
ATTN: MICHAEL NOEL KIERNAN PHONE NO : 44 179 2295283
TECHNIUM, KINGS ROAD SE DECISION MADE: 24-MAR-04
THE DOCKS 510(k) SUMMARY AVAILABLE FROM FDA
SWANSEA, WALES, UNITED KINGDOM SA1 8PH
DEVICE: MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)
DADE BEHRING, INC. 510(k) NO: K033948(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
2040 ENTERPRISE BLVD. SE DECISION MADE: 01-MAR-04
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOMD-AC
DANISH DIAGNOSTIC DEVELOPMENT A/S 510(k) NO: K040616(ABBREVIATED)
ATTN: NIELS SORENSEN PHONE NO : 454 576 8888
DR. NEERGAARDSVEJ 5F SE DECISION MADE: 24-MAR-04
HORSHOLM, DENMARK 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
DATEX-OHMEDA 510(k) NO: K032803(TRADITIONAL)
ATTN: DAN KOSEDNAR PHONE NO : 608-221-1551
PO BOX 7550 SE DECISION MADE: 10-MAR-04
MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUCERAM PLUS CERAMIC SYSTEM
DENTSPLY INTL. 510(k) NO: K040420(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
221 WEST PHILADELPHIA STREET SE DECISION MADE: 18-MAR-04
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: DUCERAGOLD PORCELAINS
DENTSPLY INTL. 510(k) NO: K040421(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
221 WEST PHILADELPHIA STREET SE DECISION MADE: 18-MAR-04
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: CARRARA INTERACTION CERAMIC SYSTEM
DENTSPLY INTL. 510(k) NO: K040635(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
221 WEST PHILADELPHIA STREET SE DECISION MADE: 30-MAR-04
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: SPECTRUM MODULAR SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K033893(TRADITIONAL)
ATTN: DINA L WEISSMAN, J.D. PHONE NO : 574-371-4905
700 ORTHOPAEDIC DR. SE DECISION MADE: 12-MAR-04
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERLIN SPINE SYSTEM
DEPUY SPINE,INC 510(k) NO: K033901(TRADITIONAL)
ATTN: JENNIFER MOONEY PHONE NO : 508-828-3649
325 PARAMONT DRIVE SE DECISION MADE: 31-MAR-04
RAYNHAM, MA 02780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMAWAVE 5000 COMBI MAX SYSTEM
DERMAWAVE, LLC 510(k) NO: K040121(TRADITIONAL)
ATTN: ALAN BUNTING PHONE NO : 561-784-0599
15693 83RD LANE NORTH SE DECISION MADE: 17-MAR-04
LOXAHATCHEE, FL 33470 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K033921(TRADITIONAL)
ATTN: NANCY OLSCAMP PHONE NO : 902 566 1396
16 MCCARVILLE ST. SE DECISION MADE: 10-MAR-04
CHARLOTTETOWN, CANADA C1E 2A6 510(k) STATEMENT
DEVICE: CALIBRATING MATERIAL, CALIBRATING STANDARDS
DIAMOND DIAGNOSTICS, INC. 510(k) NO: K033060(TRADITIONAL)
ATTN: LINDA M STUNDTNER PHONE NO : 508-429-0450
331 FISKE ST. SE DECISION MADE: 04-MAR-04
HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIXION HIP SYSTEM
DISC-O-TECH MEDICAL TECHNOLOGIES, 510(k) NO: K032730(TRADITIONAL)
ATTN: HILA WACHSLER-AVRAHAMI PHONE NO : 972 9 9511511
3 HASADNAOT SE DECISION MADE: 26-MAR-04
HERZELIA, ISRAEL 46728 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION VPS IMPRESSION MATERIAL
DISCUS DENTAL INC. 510(k) NO: K040053(TRADITIONAL)
ATTN: STEVEN L ZIEMBA PHONE NO : 310-845-8345
8550 HIGUERA ST. SE DECISION MADE: 25-MAR-04
CULVER CITY, CA 90232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAFLEX INFUSION SET
DISETRONIC MEDICAL SYSTEMS AG 510(k) NO: K033892(TRADITIONAL)
ATTN: SCOTT THIEL PHONE NO : 317-521-3362
9115 HAGUE ROAD SE DECISION MADE: 09-MAR-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 23
DOLPHIN MEDICAL INC. 510(k) NO: K033876(SPECIAL)
ATTN: BILL CURNAN PHONE NO : 720-348-0389
9433 S. MORNING GLORY LN. SE DECISION MADE: 11-MAR-04
LITTLETON, CO 80130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY MODULAR MONITORS VF4 MODIFICATIONS
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K033694(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7503
16 ELECTRONICS AVE. SE DECISION MADE: 22-MAR-04
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K033807(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 09-MAR-04
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
DRAEGER MEDICAL, INC. 510(k) NO: K030624(TRADITIONAL)
ATTN: MICHAEL A KELHART PHONE NO : 215-721-5400
3135 QUARRY RD. SE DECISION MADE: 17-MAR-04
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZTI IMPLANTS SYSTEM, DRM IMPLANTS
DRM RESEARCH LABORATORIES, INC. 510(k) NO: K034067(TRADITIONAL)
ATTN: SAMUEL WAKNINE PHONE NO : 203-488-5555
29 BUSINESS PARK DR. SE DECISION MADE: 08-MAR-04
BRANFORD, CT 06405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEGVISION, MODEL EQ1000C SERIES
EAGLE TECHNOLOGY, INC. 510(k) NO: K040051(TRADITIONAL)
ATTN: LEWIS FISHER PHONE NO : 505-428-2221
25 BISBEE COURT SE DECISION MADE: 24-MAR-04
SUITE B 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE, NM 87508-1338
DEVICE: SMART KLAMP VARIOUS BY SIZE
EMERGO GROUP, INC. 510(k) NO: K032091(TRADITIONAL)
ATTN: RENE' VAN DE ZANDE PHONE NO : 301-762-2828
2454 MCMULLEN BOOTH ROAD SE DECISION MADE: 08-MAR-04
SUITE 427 510(k) SUMMARY AVAILABLE FROM FDA
CLERWATER, FL 33759
DEVICE: ULTRASOUND IMAGING SYSTEM, MODEL 7300
ESAOTE S.P.A. 510(k) NO: K040596(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE SE DECISION MADE: 31-MAR-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM
ESSEX CRYOGENICS OF MISSOURI, INC.510(k) NO: K033000(TRADITIONAL)
ATTN: ELIZABETH HUNNICUTT PHONE NO : 314-832-8077
8007 CHIVVIS DR. SE DECISION MADE: 22-MAR-04
ST. LOUIS, MO 63123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS
ETHOX CORP. 510(k) NO: K040286(ABBREVIATED)
ATTN: EON VERRALL PHONE NO : 716-842-4000
251 SENECA ST. SE DECISION MADE: 15-MAR-04
BUFFALO, NY 14204 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO ORIA TOP CLIP SYSTEM
EUROSURGICAL S.A. 510(k) NO: K040346(SPECIAL)
ATTN: KAREN E WARDEN PHONE NO : 304-598-0525
7000 HAMPTON CENTER SE DECISION MADE: 12-MAR-04
SUITE G1 510(k) SUMMARY AVAILABLE FROM FDA
MORGANTOWN, WV 26505
DEVICE: MODIFICATION TO NITREX NITINOL GUIDEWIRE
EV3 INC 510(k) NO: K040345(SPECIAL)
ATTN: CAROLYN ANDERSON PHONE NO : 763-398-7000
4600 NATHAN LN. NORTH SE DECISION MADE: 02-MAR-04
PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMU128S, MODEL EX-NW-128S
EXCEL TECH. LTD. 510(k) NO: K040360(SPECIAL)
ATTN: CAMERON MAHON PHONE NO : 905 829 5300
2568 BRISTOL CIRCLE RD. SE DECISION MADE: 12-MAR-04
OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRO TARGETING ELECTRODE
FHC, INC. 510(k) NO: K033173(TRADITIONAL)
ATTN: FREDERICK HAER PHONE NO : 207-666-8190
9 MAIN ST. SE DECISION MADE: 24-MAR-04
BOWDOINHAM, ME 04008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESSURE MANIFOLD, MODEL BC 110
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K040366(TRADITIONAL)
ATTN: ROBERT PETRY PHONE NO : 011 64 95740123
15 MAURICE PAYKEL PLACE SE DECISION MADE: 04-MAR-04
EAST TAMAKI, NEW ZEALAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P
FLIR SYSTEMS 510(k) NO: K033967(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 09-MAR-04
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500
GE MEDICAL SYSTEMS NAVIGATION AND 510(k) NO: K040050(TRADITIONAL)
ATTN: JEFF WAGNER PHONE NO : 801-328-9300
384 WRIGHT BROTHERS DRIVE SE DECISION MADE: 24-MAR-04
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTSPEED 7.0 CT SCANNER SYSTEM
GE MEDICAL SYSTEMS, LLC 510(k) NO: K040372(TRADITIONAL)
ATTN: JOHN W JAECKLE PHONE NO : 262-312-7358
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 01-MAR-04
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGE
GEBAUER CO. 510(k) NO: K032671(TRADITIONAL)
ATTN: AMY J PAUKOVITS PHONE NO : 216-271-5252
9410 ST. CATHERINE AVE. SE DECISION MADE: 17-MAR-04
CLEVELAND, OH 44104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOBOY
GEYSER S.A. 510(k) NO: K033644(TRADITIONAL)
ATTN: FRANCOIS FOURNIER PHONE NO : 508-643-0434
ZONE ARTISANALE DE PERACHE SE DECISION MADE: 24-MAR-04
COUDES, FRANCE 63114 510(k) STATEMENT
DEVICE: VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGE
GISH BIOMEDICAL, INC. 510(k) NO: K040355(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 832-285-9423
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 15-MAR-04
HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE
GLOBAL ORTHOPAEDIC TECHNOLOGY, USA510(k) NO: K033351(TRADITIONAL)
ATTN: CARL KNOBLOCH PHONE NO : 407-977-8609
5349 RED LEAF COURT SE DECISION MADE: 11-MAR-04
OVIEDO, FL 32765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUSTAIN RADIOLUCENT SPACER
GLOBUS MEDICAL, INC. 510(k) NO: K040284(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000
303 SCHELL LANE SE DECISION MADE: 23-MAR-04
PHOENIXVILLE, PA 19460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTOFLEX 100 TYE 1012
GN OTOMETRICS A/S 510(k) NO: K033645(TRADITIONAL)
ATTN: PER PAPE THOMSEN PHONE NO : 45 721 11555
DYBENDALSVAENGET 2 SE DECISION MADE: 31-MAR-04
P.O. BOX 119 510(k) SUMMARY AVAILABLE FROM FDA
TAASTRUP, DENMARK DK-2630
DEVICE: RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568
GUIDANT CORPORATION 510(k) NO: K031903(TRADITIONAL)
ATTN: STEPHANIE I ROBINSON PHONE NO : 651-582-4927
4100 HAMLINE AVE NORTH SE DECISION MADE: 03-MAR-04
ST PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX
GUNTER BISSINGER MEDIZINTECHNIK GM510(k) NO: K033177(SPECIAL)
ATTN: DAGMAR MASER PHONE NO : 011 312 04289591
AMSTEL 320-I SE DECISION MADE: 11-MAR-04
AMSTERDAM, NETHERLANDS 1017 AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSAPOINT RESECTOSCOPIC SYSTEM
GYNECARE, A DIV. OF ETHICON, INC. 510(k) NO: K040302(SPECIAL)
ATTN: PATRICIA M HOJNOSKI PHONE NO : 908-218-2893
U.S. ROUTE 22 WEST SE DECISION MADE: 09-MAR-04
P.O.BOX 151 510(k) SUMMARY AVAILABLE FROM FDA
SOMERVILLE, NJ 08876
DEVICE: DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
GYRUS ENT L.L.C. 510(k) NO: K034004(TRADITIONAL)
ATTN: ALICIA FARAGE PHONE NO : 901-373-0200
2925 APPLING RD. SE DECISION MADE: 03-MAR-04
BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TI CLIP APPLIER
GYRX, LLC 510(k) NO: K034029(TRADITIONAL)
ATTN: BRIAN S ZIMOVAN PHONE NO : 904-641-2599
11222 ST. JOHNS INDUSTRIAL SE DECISION MADE: 05-MAR-04
PARKWAY N. 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: TRAPMATIC SYSTEM SET
H.S HOSPITAL SERVICE S.P.A. 510(k) NO: K033616(TRADITIONAL)
ATTN: LUCIO IMPROTA PHONE NO : 561-443-3321
1200 CLINT MOORE RD SE DECISION MADE: 01-MAR-04
SUITE 1 510(k) SUMMARY AVAILABLE FROM FDA
BOCA RATON, FL 33487
DEVICE: ROBERTSITE VIAL ADAPTER, MODEL 245700021
HALKEY-ROBERTS CORP. 510(k) NO: K040634(TRADITIONAL)
ATTN: JOHN SHELDON PHONE NO : 727-577-1300
11600 M.L. KING BLVD.,NORTH SE DECISION MADE: 23-MAR-04
ST. PETERSBURG, FL 33716 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE
HARRY J. BOSWORTH CO. 510(k) NO: K040547(TRADITIONAL)
ATTN: MILDRED GOLDSTEIN PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVE. SE DECISION MADE: 19-MAR-04
SKOKIE, IL 60076 510(k) STATEMENT
DEVICE: AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE
HARRY J. BOSWORTH CO. 510(k) NO: K040548(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVE. SE DECISION MADE: 19-MAR-04
SKOKIE, IL 60076 510(k) STATEMENT
DEVICE: NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO
HDC CORP. 510(k) NO: K023342(TRADITIONAL)
ATTN: EARL SMART PHONE NO : 408-942-7340
628 GIBRALTAR COURT SE DECISION MADE: 02-MAR-04
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALTH BUDDY WITH BUDDYLINK
HEALTH HERO NETWORK, INC. 510(k) NO: K040086(TRADITIONAL)
ATTN: GEOFFREY CLAPP PHONE NO : 650-559-1088
2570 WEST EL CAMINO REAL SE DECISION MADE: 10-MAR-04
SUITE 111 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94040-1309
DEVICE: HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABON
HERAEUS KULZER GMBH 510(k) NO: K034049(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 01-MAR-04
SOUTH BEND, IN 46614-2517 510(k) STATEMENT
DEVICE: NDX-40 ALLOY
HERAEUS KULZER, INC. 510(k) NO: K040043(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 03-MAR-04
SOUTH BEND, IN 46614-2517 510(k) STATEMENT
DEVICE: TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST S
HOME DIAGNOSTICS, INC. 510(k) NO: K032657(TRADITIONAL)
ATTN: KAREN DEVINCENT PHONE NO : 954-677-9201
2400 N.W. 55TH CT. SE DECISION MADE: 24-MAR-04
FORT LAUDERDALE, FL 33309 510(k) STATEMENT
DEVICE: MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST
HOME DIAGNOSTICS, INC. 510(k) NO: K040670(SPECIAL)
ATTN: KAREN DEVINCENT PHONE NO : 954-677-9201
2400 N.W. 55TH CT. SE DECISION MADE: 25-MAR-04
FORT LAUDERDALE, FL 33309 510(k) STATEMENT
DEVICE: BONESAVE BONE VOID FILLER
HOWMEDICA OSTEONICS 510(k) NO: K033258(TRADITIONAL)
ATTN: LORRAINE MONTEMURRO PHONE NO : 201-831-5892
59 ROUTE 17 SE DECISION MADE: 09-MAR-04
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS
HOWMEDICA OSTEONICS CORP 510(k) NO: K040128(SPECIAL)
ATTN: MARGARET F CROWE PHONE NO : 201-831-5580
325 CORPORATE DR. SE DECISION MADE: 26-MAR-04
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D1
HYPOGUARD USA, INC. 510(k) NO: K033851(TRADITIONAL)
ATTN: BRUCE MACFARLANE PHONE NO : 952-646-3188
5182 WEST 76TH ST. SE DECISION MADE: 02-MAR-04
MINNEAPOLIS, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL
IGC-MEDICAL ADVANCES, INC. 510(k) NO: K040640(TRADITIONAL)
ATTN: ANTHONY DIETZLER PHONE NO : 414-258-3808
10437 INNOVATION DR. SE DECISION MADE: 22-MAR-04
MILWAUKEE, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000
IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K033619(TRADITIONAL)
ATTN: DAVID M LEE PHONE NO : 321-309-8237
2290 EAU GALLIE BLVD. SE DECISION MADE: 02-MAR-04
MELBOURNE, FL 32935 510(k) STATEMENT
DEVICE: IMALUX OCT IMAGING SYSTEM
IMALUX COPORATION 510(k) NO: K033783(TRADITIONAL)
ATTN: STEPHANIE A.S. HARRINGTON PHONE NO : 216-502-0755
1771 EAST 30TH ST. SE DECISION MADE: 01-MAR-04
CLEVELAND, OH 44114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)
IMMCO DIAGNOSTICS, INC. 510(k) NO: K032850(TRADITIONAL)
ATTN: KEVIN LAWSON PHONE NO : 716-691-0091
60 PINEVIEW DR. SE DECISION MADE: 18-MAR-04
BUFFALO, NY 14228 510(k) STATEMENT
DEVICE: IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)
IMMCO DIAGNOSTICS, INC. 510(k) NO: K032860(TRADITIONAL)
ATTN: KEVIN J LAWSON PHONE NO : 716-691-0091
60 PINEVIEW DR. SE DECISION MADE: 18-MAR-04
BUFFALO, NY 14228 510(k) STATEMENT
DEVICE: IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TO
IMMCO DIAGNOSTICS, INC. 510(k) NO: K040095(TRADITIONAL)
ATTN: KEVIN J LAWSON PHONE NO : 716-691-0091
60 PINEVIEW DR. SE DECISION MADE: 05-MAR-04
BUFFALO, NY 14228 510(k) STATEMENT
DEVICE: IMMUNICON CELLTRACKS AUTOPREP SYSTEM
IMMUNICON CORP. 510(k) NO: K040077(TRADITIONAL)
ATTN: PETER J SCOTT PHONE NO : 215-830-0777
3401 MASONS MILL RD. SE DECISION MADE: 12-MAR-04
HUNTINGDON VALLEY, PA 19006-3574 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
IMPACT INSTRUMENTATION, INC. 510(k) NO: K032386(TRADITIONAL)
ATTN: LESLIE H SHERMAN PHONE NO : 973-882-1212
27 FAIRFIELD PL. SE DECISION MADE: 26-MAR-04
P.O. BOX 508 510(k) SUMMARY AVAILABLE FROM FDA
WEST CALDWELL, NJ 07006-0508
DEVICE: 3I PATIENT-SPECIFIC OVERDENTURE BAR
IMPLANT INNOVATIONS, INC. 510(k) NO: K034035(TRADITIONAL)
ATTN: JIM BANIC PHONE NO : 561-776-6932
4555 RIVERSIDE DR. SE DECISION MADE: 24-MAR-04
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEM
INDUSTRIAL CLOTHINGS, LTD. 510(k) NO: K033496(TRADITIONAL)
ATTN: ALBINA BIANCHI PHONE NO : 416 447 9040
255 DUNCANMILL ROAD SE DECISION MADE: 09-MAR-04
SUITE 904 510(k) STATEMENT
TORONTO, CANADA M3B 3H9
DEVICE: IDI-MRSA
INFECTIO DIAGNOSTIC (I.D.I.) INC. 510(k) NO: K033415(TRADITIONAL)
ATTN: CHRISTIAN CHOQUET PHONE NO : 418 681 4343
2050 BOUL RENE-LEVESQUE O SE DECISION MADE: 18-MAR-04
4 IEME ETAGE 510(k) SUMMARY AVAILABLE FROM FDA
SAINTE-FOY, CANADA G1V 2K8
DEVICE: INION OTPS BIODEGRADABLE MESH PLATING SYSTEM
INION LTD. 510(k) NO: K031961(TRADITIONAL)
ATTN: HANNA MARTTILA PHONE NO : 358 323 06600
LAAKARINKATU 2 SE DECISION MADE: 01-MAR-04
TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INION GTR BIODEGRADABLE MEMBRANE SYSTEM
INION LTD. 510(k) NO: K033074(TRADITIONAL)
ATTN: HANNA MARTTILA PHONE NO : 358 323 06600
LAAKARINKATU 2 SE DECISION MADE: 31-MAR-04
TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE FRIENDLYLIGHT ND: YAG LASERS
INNOTECH USA, INC. 510(k) NO: K033251(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
COLUMBIA SQUARE SE DECISION MADE: 02-MAR-04
555 THIRTEENTH STREET, NW 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC, DC
DEVICE: I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2
INNOVA VISION INC. 510(k) NO: K033136(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 05-MAR-04
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA PLEX SLE PROFILE 8
INOVA DIAGNOSTICS, INC. 510(k) NO: K040160(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 858-586-9900
10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 08-MAR-04
SAN DIEGO, CA 92131 510(k) STATEMENT
DEVICE: ELLIPTIC MATRIX
INSTITUT STRAUMANN AG 510(k) NO: K040539(SPECIAL)
ATTN: JOHN KING PHONE NO : 800-448-8168
RESERVOIR PLACE SE DECISION MADE: 18-MAR-04
1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02451
DEVICE: HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
INSTRUMENTATION LABORATORY CO. 510(k) NO: K040359(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 19-MAR-04
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS
INTRA-LOCK INTERNATIONAL 510(k) NO: K040205(ABBREVIATED)
ATTN: JEFFERY SAKOFF PHONE NO : 561-447-8282
1200 NORTH FEDERAL HWY SE DECISION MADE: 22-MAR-04
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
BOCA RATON, FL 33432
DEVICE: MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSS
INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K040037(SPECIAL)
ATTN: PAMELA MISAJON PHONE NO : 760-918-1820
6354 CORTE DEL ABETO SE DECISION MADE: 03-MAR-04
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009
DEVICE: SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1
INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K040481(SPECIAL)
ATTN: PAMELA MISAJON PHONE NO : 760-918-1820
6354 CORTE DEL ABETO SE DECISION MADE: 18-MAR-04
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009
DEVICE: INVACARE POLARIS EX CPAP, MODEL ISP3000
INVACARE CORP. 510(k) NO: K031064(TRADITIONAL)
ATTN: JANICE BROWNLEE PHONE NO : 440-329-6595
ONE INVACARE WAY SE DECISION MADE: 12-MAR-04
P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA
ELYRIA, OH 44036-2125
DEVICE: INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000
INVACARE CORP. 510(k) NO: K031176(TRADITIONAL)
ATTN: RAE ANN FARROW PHONE NO : 440-329-6356
ONE INVACARE WAY SE DECISION MADE: 25-MAR-04
P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA
ELYRIA, OH 44036-2125
DEVICE: INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 102905
INVIRO MEDICAL 510(k) NO: K040036(TRADITIONAL)
ATTN: JIM BARLEY PHONE NO : 949-364-9349
28481 LA FALDA SE DECISION MADE: 18-MAR-04
LAGUNA NIGUEL, CA 92677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IVY DEVICES INC. IV/MEDICAL LINE STABILIZER
IVY DEVICES, INC. 510(k) NO: K033208(TRADITIONAL)
ATTN: WILLIAM REILLY PHONE NO : 509-627-6428
P.O. BOX 23241 SE DECISION MADE: 18-MAR-04
GRANDE PRAIRIE, ALBERTA, CANADA T8510(k) STATEMENT
DEVICE: JSA'S REPROCESSED COMPRESSION SLEEVE DEVICES
JACK SPEER AND ASSOC., INC. 510(k) NO: K040065(TRADITIONAL)
ATTN: JACK SPEER PHONE NO : 801-582-6470
1800 EAST 900 SOUTH SE DECISION MADE: 29-MAR-04
SALT LAKE CITY, UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLUME SAFETY AVF NEEDLE
JMS NORTH AMERICA CORP. 510(k) NO: K040247(SPECIAL)
ATTN: CHONG SWEE CHEAU PHONE NO : 510-888-9090
22320 FOOTHILL BLVD., SE DECISION MADE: 03-MAR-04
SUITE 350 510(k) STATEMENT
HAYWARD, CA 94541
DEVICE: KAEN YIH UMBILICAL CORD CLAMP
KAEN YIH ENTERPRISE CO., LTD. 510(k) NO: K033846(TRADITIONAL)
ATTN: ANTONIO L GIACCIO PHONE NO : 815-385-0100
1202 S. RTE. 31 SE DECISION MADE: 11-MAR-04
MCHENRY, IL 60050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KENKOWAVE INFRARED PAIN TREATMENT SYSTEM
KAYLIGHT CORPORATION 510(k) NO: K033555(TRADITIONAL)
ATTN: DAVID R BALZER PHONE NO : 203-263-5951
669 MAIN STREET SOUTH, STE 7 SE DECISION MADE: 02-MAR-04
WOODBURY, CT 06798 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: NAVIPRO KNEE SOFTWARE MODULE
KINAMED, INC. 510(k) NO: K033668(TRADITIONAL)
ATTN: VINEET K SARIN PHONE NO : 805-384-2748
820 FLYNN RD. SE DECISION MADE: 11-MAR-04
CAMARILLO, CA 93012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOMPRESSOR SCREW SYSTEM
KINETIKOS MEDICAL, INC. 510(k) NO: K040356(SPECIAL)
ATTN: JOHN G SPAMPINATO PHONE NO : 760-448-1706
6005 HIDDEN VALLEY RD, STE 180 SE DECISION MADE: 01-MAR-04
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KERATO ANALYZER (EKA)
KONAN MEDICAL, INC. 510(k) NO: K040373(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SOUTH SE DECISION MADE: 19-MAR-04
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARFIL PHOTO CORE PLT
KURARAY MEDICAL INC. 510(k) NO: K033970(TRADITIONAL)
ATTN: SATOSHI YAMAGUCHI PHONE NO : 212-986-2230
101 EAST 52ND STREET, 26TH FL. SE DECISION MADE: 26-MAR-04
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LABONE COCAINE METABOLITE MICRO-PLATE EIA
LABONE, INC. 510(k) NO: K040198(TRADITIONAL)
ATTN: LIUMING YU PHONE NO : 913-895-2308
10101 RENNER BLVD. SE DECISION MADE: 05-MAR-04
LENEXA, KS 66219 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FLEBOSET MULTIPLE
LABORATORIOS GRIFOLS, S.A. 510(k) NO: K040456(TRADITIONAL)
ATTN: SEBASTIAN GASCON PHONE NO : 349 357 10100
C/CAN GUASCH, 2 SE DECISION MADE: 09-MAR-04
PARETS DEL VALLES, BARCELONA, SPAI510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
LASERSCOPE 510(k) NO: K034011(TRADITIONAL)
ATTN: PAUL HARDIMAN PHONE NO : 800-243-9384
3070 ORCHARD DR. SE DECISION MADE: 30-MAR-04
SAN JOSE, CA 95134-2011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
LATEXX MANUFACTURING SDN.BHD. 510(k) NO: K034052(TRADITIONAL)
ATTN: LAW SIAU WOEI (TERRY LAW) PHONE NO : 201-488-8086
216 CHARLES ST. SE DECISION MADE: 15-MAR-04
HACKENSACK, NJ 07601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED SONAMET BODY COMPOSITION ANALYZER
LIFE MEASUREMENT, INC. 510(k) NO: K032610(ABBREVIATED)
ATTN: SHELIA W PICKERING PHONE NO : 650-969-6114
2081 LONGDEN CIRCLE SE DECISION MADE: 01-MAR-04
LOS ATLAS, CA 94024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LSI SEW-RIGHT "R" SERIES SUTURE PLACEMENT DEVICE AND ACCESS PROD
LSI SOLUTIONS 510(k) NO: K040232(SPECIAL)
ATTN: CHRISTOPHER A KLACZYK PHONE NO : 585-869-6600
7796 VICTOR-MENDON RD. SE DECISION MADE: 01-MAR-04
VICTOR, NY 14564 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOW PROFILE LUTHER SAFETY HUBER
LUTHER NEEDLESAFE PRODUCTS, INC. 510(k) NO: K040527(SPECIAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 26-MAR-04
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
MASIMO CORP. 510(k) NO: K033998(TRADITIONAL)
ATTN: JAMES J CRONIN PHONE NO : 949-250-9688
2852 KELVIN AVE. SE DECISION MADE: 19-MAR-04
IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 30
MATSUSHITA ELECTRIC WORKS, LTD. 510(k) NO: K033894(TRADITIONAL)
ATTN: CAROLANN KOTULA PHONE NO : 770-985-8203
55 NORTHERN BLVD. SE DECISION MADE: 11-MAR-04
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: ELECTRO-LUBE
MECTRA LABS, INC. 510(k) NO: K033880(TRADITIONAL)
ATTN: CHARLES E ALLGOOD JR. PHONE NO : 812-384-3521
HIGHWAY 231 SOUTH, SE DECISION MADE: 10-MAR-04
2 QUALITY WAY 510(k) STATEMENT
BLOOMFIELD, IN 47424
DEVICE: PANORET, MODEL PNM 60
MEDIBELL MEDICAL VISION TECHNOLOGI510(k) NO: K040325(SPECIAL)
ATTN: DAN LAOR PHONE NO : 972 4 8566220
MATAM HIGHT TECHNOLOGIES CTR SE DECISION MADE: 08-MAR-04
HAIFA, ISRAEL 31905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX NRG
MEDIC NRG LTD. 510(k) NO: K032743(TRADITIONAL)
ATTN: ADI ICKOWICZ PHONE NO : 972 3 9233666
POB 367 SE DECISION MADE: 15-MAR-04
RAMAT HASHARON, ISRAEL 47103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MLT-1000 IR LASER SYSTEM
MEDICAL LASER THERAPEUTICS LP 510(k) NO: K033986(TRADITIONAL)
ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433
12101-A CULLEN BLVD. SE DECISION MADE: 29-MAR-04
HOUSTON, TX 77047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLAR GI SYSTEM
MEDICAL MEASUREMENT SYSTEMS,B.V. 510(k) NO: K031084(TRADITIONAL)
ATTN: KARIN OGINK-SOMHORST PHONE NO : 315 348 03700
COLOSSEUM 25 SE DECISION MADE: 19-MAR-04
PV ENSCHEDE, NETHERLANDS 7521 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIGH SPEED EMG MODULE
MEDICAL MEASUREMENT SYSTEMS,B.V. 510(k) NO: K031930(TRADITIONAL)
ATTN: KARIN OGINK-SOMHORST PHONE NO : 315 348 03700
COLOSSEUM 25 SE DECISION MADE: 03-MAR-04
PV ENSCHEDE, NETHERLANDS 7521 510(k) STATEMENT
DEVICE: CT-MASS
MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K033774(TRADITIONAL)
ATTN: J.I. HOLLANDER PHONE NO : 31 71 5223244
SCHUTTERSVELD 9 SE DECISION MADE: 02-MAR-04
LEIDEN, NETHERLANDS 2316 XG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENDERWET ACTIVE
MEDLINE INDUSTRIES, INC. 510(k) NO: K040517(TRADITIONAL)
ATTN: ANDREA HAFERKAMP PHONE NO : 847-837-2759
ONE MEDLINE PL. SE DECISION MADE: 25-MAR-04
MUNDELEIN, IL 60060 510(k) STATEMENT
DEVICE: MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE
MEDRAD, INC. 510(k) NO: K033881(SPECIAL)
ATTN: TROY A JACK PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 02-MAR-04
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEDIATRIC AORTIC ROOT CANNULA
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K040173(SPECIAL)
ATTN: RONALD W BENNETT PHONE NO : 763-391-9086
7611 NORTHLAND DR. SE DECISION MADE: 19-MAR-04
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARROWHEAD SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K032560(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 09-MAR-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VERTE-STACK
MEDTRONIC SOFAMOR DANEK 510(k) NO: K040422(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 19-MAR-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K040583(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 31-MAR-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1
MEDTRONIC, INC. 510(k) NO: K033050(TRADITIONAL)
ATTN: MAC MCKEEN PHONE NO : 763-514-3687
7000 CENTRAL AVE. NE SE DECISION MADE: 26-MAR-04
MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS
MEDTRONIC, INC. 510(k) NO: K040568(SPECIAL)
ATTN: DOUG ATKINS PHONE NO : 763-505-0204
710 MEDTRONIC PARKWAY NE SE DECISION MADE: 25-MAR-04
MINNEAPOLIS, MN 55432-5604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOFLEX TRACHEAL TUBE
MERLYN ASSOCIATES INC. 510(k) NO: K031794(TRADITIONAL)
ATTN: CHING CHING SEAH, PH.D. PHONE NO : 518-792-2258
AMSINO INTERNATIONAL INC. SE DECISION MADE: 12-MAR-04
4501 BRICKELL PRIVADO 510(k) SUMMARY AVAILABLE FROM FDA
ONTARIO, CA 91761
DEVICE: LIQUID OXYGEN SYSTEM
MICRO TECHNOLOGY SERVICES, INC. 510(k) NO: K032143(TRADITIONAL)
ATTN: TOMMY BUIE PHONE NO : 972-231-6874
1819 FIRMAN, SUITE 137 SE DECISION MADE: 30-MAR-04
RICHARDSON, TX 75081 510(k) STATEMENT
DEVICE: MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)
MICRO THERAPEUTICS, INC. 510(k) NO: K040694(SPECIAL)
ATTN: FLORIN TRUUVERT PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 25-MAR-04
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K040002(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD. SE DECISION MADE: 22-MAR-04
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: MICROOPTICAL'S CRITICAL DATA VIEWERS, MODELS MD-3 AND MD-6
MICROOPTICAL CORPORATION 510(k) NO: K040244(TRADITIONAL)
ATTN: DANIEL J DILLON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 24-MAR-04
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RTIST
MIRADA SOLUTIONS LTD 510(k) NO: K033955(TRADITIONAL)
ATTN: MARIA EBIO PHONE NO : 865-218-2534
810 INNOVATION DRIVE SE DECISION MADE: 17-MAR-04
KNOXVILLE, TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOCRYL RAPIDE INTERFERENCE SCREW
MITEK WORLDWIDE 510(k) NO: K032717(TRADITIONAL)
ATTN: KAREN K SYLVIA PHONE NO : 781-251-2704
A JOHNSON & JOHNSON COMPANY SE DECISION MADE: 31-MAR-04
249 VANDERBILT AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
NORWOOD, MA 02062
DEVICE: ONEUSE- PLUS MICROKERATOME
MORIA S.A. 510(k) NO: K040297(TRADITIONAL)
ATTN: MELANIE RENAUD-SAMIRI PHONE NO : 331 467 44636
15 RUE GEORGES BESSE SE DECISION MADE: 31-MAR-04
ANTONY, FRANCE 92160 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QSC-127-INT SHOULDER ARRAY COIL SET
MRI DEVICES CORP. 510(k) NO: K040288(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 05-MAR-04
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K040348(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 09-MAR-04
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: MODIFICATION TO HRW-127 WRIST ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K040349(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 09-MAR-04
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT),
NAKANISHI, INC. 510(k) NO: K031421(TRADITIONAL)
ATTN: MASAYUKI ONOGUCHI PHONE NO : 847-843-7664
700B COOPER COURT SE DECISION MADE: 26-MAR-04
SCHAUMBURG, IL 60173 510(k) STATEMENT
DEVICE: MEDIPACS
NEOBIT CO., LTD. 510(k) NO: K040486(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 11-MAR-04
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR
NEWMEDICAL TECHNOLOGY, INC. 510(k) NO: K040064(TRADITIONAL)
ATTN: HAITHAM MATLOUB PHONE NO : 262-271-8799
N.14 W.23833 STONE RIDGE DR. SE DECISION MADE: 23-MAR-04
SUITE G100, MAIL BOX #1 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53188
DEVICE: MARK 5 NUVO (M5C5)
NIDEK MEDICAL PRODUCTS, INC. 510(k) NO: K032509(TRADITIONAL)
ATTN: JENNIFER MCWILLIAMS PHONE NO : 205-856-7200
3949 VALLEY EAST INDUSTRIAL DR SE DECISION MADE: 18-MAR-04
BIRMINGHAM, AL 35217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HS
NMT MEDICAL, INC. 510(k) NO: K034025(TRADITIONAL)
ATTN: ANNE M KULIS PHONE NO : 617-737-0930
27-43 WORMWOOD ST. SE DECISION MADE: 26-MAR-04
BOSTON, MA 02210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL AVANT 2120 PULSE OXIMETER AND NIBP
NONIN MEDICAL, INC. 510(k) NO: K031487(TRADITIONAL)
ATTN: RICHARD P BENNETT PHONE NO : 763-577-3166
2605 FERNBROOK LANE, NORTH SE DECISION MADE: 22-MAR-04
MINNEAPOLIS, MN 55447-4755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE
NOVABONE PRODUCTS, LLC 510(k) NO: K033994(TRADITIONAL)
ATTN: DAVID M GAISSER PHONE NO : 386-462-7660
ONE PROGRESS BLVD. SE DECISION MADE: 25-MAR-04
SUITE 33 510(k) SUMMARY AVAILABLE FROM FDA
ALACHUA, FL 32615
DEVICE: PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE
NOVABONE PRODUCTS, LLC 510(k) NO: K040278(SPECIAL)
ATTN: DAVID M GAISSER PHONE NO : 386-462-7660
13709 PROGRESS BLVD., #33 SE DECISION MADE: 01-MAR-04
ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CH
OLYMPUS AMERICA, INC. 510(k) NO: K040471(SPECIAL)
ATTN: MICHAEL CAMPBELL PHONE NO : 972-556-9697
3131 WEST ROYAL LN. SE DECISION MADE: 10-MAR-04
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: POGS 33
ON SITE GAS SYSTEMS, INC. 510(k) NO: K030920(TRADITIONAL)
ATTN: FRANCIS X HURSEY PHONE NO : 888-748-3429
35 BUDNEY RD. SE DECISION MADE: 10-MAR-04
BUDNEY INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
NEWINGTON,, CT 06111
DEVICE: ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4
ORAL OSTEODISTRACTION, L.P. 510(k) NO: K034045(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 23-MAR-04
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
ORBUS MEDICAL TECHNOLOGIES 510(k) NO: K040550(SPECIAL)
ATTN: JIM CLOSSICK PHONE NO : 954-730-0711
5363 N.W. 35TH AVE. SE DECISION MADE: 16-MAR-04
FT. LAUDERDALE, FL 33309-6315 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESTFUL NIGHTS, IST-APPLIANCE
OTTAWA DENTAL LABORATORY 510(k) NO: K021569(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 888-729-9674
P.O. BOX 4341 SE DECISION MADE: 15-MAR-04
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: PAJUNK MODULAR HANDLE INSTRUMENTS
PAJUNK GMBH 510(k) NO: K033249(TRADITIONAL)
ATTN: LYNETTE L HOWARD PHONE NO : 908-788-4580
203 MAIN STREET, PMB 166 SE DECISION MADE: 05-MAR-04
FLEMINGTON,, NJ 08822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STARLUX PULSED LIGHT SYSTEM
PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K033549(TRADITIONAL)
ATTN: MARCY MOORE PHONE NO : 781-993-2300
82 CAMBRIDGE ST. SE DECISION MADE: 10-MAR-04
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND TH
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K040357(SPECIAL)
ATTN: DAVE OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD. SE DECISION MADE: 03-MAR-04
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K040304(SPECIAL)
ATTN: HAUKE SCHIK PHONE NO : 49 703 14632031
HEWLETT-PACKARD STR.2 SE DECISION MADE: 01-MAR-04
BOEBLINGEN, BADEN-WTTBG, GERMANY D510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAAS II RVA
PIE MEDICAL IMAGING B.V. 510(k) NO: K033920(TRADITIONAL)
ATTN: CARLA DE VRIES PHONE NO : 31 43 3281322
BECANUSSTRAAT 13 DO1 SE DECISION MADE: 17-MAR-04
MAASTRICHT, NETHERLANDS 6216 BX 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KRYO ART CONTROLLED RATE FREEZER
PLANER PLC 510(k) NO: K032086(TRADITIONAL)
ATTN: DAVID S SCHLERF PHONE NO : 925-356-2649
200 GREGORY LANE SE DECISION MADE: 19-MAR-04
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389
DEVICE: PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CA
PORTEX, INC. 510(k) NO: K033080(TRADITIONAL)
ATTN: CINDY ENGELHARDT PHONE NO : 603-352-3812
10 BOWMAN DR. SE DECISION MADE: 10-MAR-04
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS
POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K040398(TRADITIONAL)
ATTN: BARBARA J WHITMAN PHONE NO : 267-775-8151
110 UNION SQUARE DR. SE DECISION MADE: 24-MAR-04
NEW HOPE, PA 18938-1364 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERLITE 600 EX SYSTEM
PRESWEDE AB 510(k) NO: K033933(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD. SE DECISION MADE: 16-MAR-04
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: THE ULTRA SYSTEM
PROMEDICA, INC. 510(k) NO: K032445(TRADITIONAL)
ATTN: RICHARD BLOOM PHONE NO : 813-889-9250
114 DOUGLAS RD EAST SE DECISION MADE: 29-MAR-04
OLDSMAR, FL 34677 510(k) STATEMENT
DEVICE: R&D; GLU-LINE HEMATOLOGY CONTROL
R & D SYSTEMS, INC. 510(k) NO: K034048(TRADITIONAL)
ATTN: RALPH E HOGANCAMP PHONE NO : 612-656-4413
614 MCKINLEY PL., N.E. SE DECISION MADE: 10-MAR-04
MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHEETAH WHEELCHAIR
R82 A/S 510(k) NO: K033460(TRADITIONAL)
ATTN: KIRK MACKENZIE PHONE NO : 704-882-0668
12801 EAST INDEPENDENCE BLVD. SE DECISION MADE: 26-MAR-04
STALLINGS, NC 28105 510(k) STATEMENT
DEVICE: TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
RADI MEDICAL SYSTEMS AB 510(k) NO: K033291(TRADITIONAL)
ATTN: HELENE EKSTRAND PHONE NO : 461 816 1000
PALMBLADSGATAN 10 SE DECISION MADE: 17-MAR-04
UPPSALA, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX LIQUID CRP CONTROLS
RANDOX LABORATORIES, LTD. 510(k) NO: K040351(TRADITIONAL)
ATTN: P. ARMSTRONG PHONE NO : 44 28 94422413
55 DIAMOND RD. SE DECISION MADE: 12-MAR-04
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA
RAVEN BIOLOGICAL LABORATORIES, INC510(k) NO: K031114(TRADITIONAL)
ATTN: WENDY ROYALTY-HANN PHONE NO : 402-593-0781
8607 PARK DR. SE DECISION MADE: 03-MAR-04
OMAHA, NE 68127 510(k) STATEMENT
DEVICE: TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002
REMOTE DIAGNOSTIC TECHNOLOGIES LTD510(k) NO: K033410(TRADITIONAL)
ATTN: CHRIS HANNAN PHONE NO : 441 256 362400
THE OLD COACH HOUSE, THE AV. SE DECISION MADE: 05-MAR-04
FARLEIGH WALLOP, BASINGSTOKE 510(k) SUMMARY AVAILABLE FROM FDA
HAMPSHIRE, UNITED KINGDOM RG25 2HTTHIRD PARTY REVIEW
DEVICE: S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP
RESMED CORP. 510(k) NO: K030797(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 10-MAR-04
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESMED S8 PRIME CPAP SYSTEM
RESMED LTD. 510(k) NO: K033841(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2282
14040 DANIELSON ST. SE DECISION MADE: 10-MAR-04
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLV CONTINUUM VENTILATOR, MODEL P2000
RESPIRONICS CALIFORNIA, INC. 510(k) NO: K034032(TRADITIONAL)
ATTN: MARY FUNK PHONE NO : 760-918-7300
2271 COSMOS CT. SE DECISION MADE: 16-MAR-04
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIPAP PRO 2 BI-LEVEL SYSTEM
RESPIRONICS, INC. 510(k) NO: K032834(TRADITIONAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 04-MAR-04
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALICE 5
RESPIRONICS, INC. 510(k) NO: K040595(ABBREVIATED)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 18-MAR-04
MURRYSVILLE, PA 15668-8550 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
REVIVANT CORP. 510(k) NO: K040453(SPECIAL)
ATTN: BOB H KATZ PHONE NO : 408-524-3500
775 PALOMAR AVE. SE DECISION MADE: 11-MAR-04
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MESACUP-2 TEST CENP-B
RHIGENE, INC. 510(k) NO: K040200(TRADITIONAL)
ATTN: YUSUKE KOBE PHONE NO : 847-375-9091
455 STATE ST., SE DECISION MADE: 04-MAR-04
SUITE 104 510(k) SUMMARY AVAILABLE FROM FDA
DES PLAINES, IL 60016
DEVICE: MESACUP TEST MPO, MODEL 11053
RHIGENE, INC. 510(k) NO: K040586(TRADITIONAL)
ATTN: NANCI DEXTER PHONE NO : 303-457-4345
12061 TEJON ST. SE DECISION MADE: 22-MAR-04
WESTMINSTER, CO 80234 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RNK TELEPHONIC STETHOSCOPE, MODEL TR-1
RNK PRODUCTS 510(k) NO: K034046(TRADITIONAL)
ATTN: CHARLES R ABBRUSCATO PHONE NO : 612-414-0289
12700 DIAMOND DRIVE SE DECISION MADE: 10-MAR-04
BURNSVILLE, MN 55337 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (
ROCHE DIAGNOSTICS CORP. 510(k) NO: K040245(TRADITIONAL)
ATTN: THERESA M AMBROSE PHONE NO : 317-521-3723
9115 HAGUE RD. SE DECISION MADE: 24-MAR-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR
ROCHE DIAGNOSTICS CORP. 510(k) NO: K040280(TRADITIONAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 11-MAR-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
ROCHE DIAGNOSTICS CORP. 510(k) NO: K040431(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 10-MAR-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
ROCHE DIAGNOSTICS CORP. 510(k) NO: K040434(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 10-MAR-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
ROCHE DIAGNOSTICS CORP. 510(k) NO: K040435(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 10-MAR-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETISCAN, RETIPORT
ROLAND CONSULT 510(k) NO: K023525(ABBREVIATED)
ATTN: MATTHIAS MAI PHONE NO : 493 381 382621
FRIEDRICH-FRANZ-STRASSE 19 SE DECISION MADE: 26-MAR-04
BRANDENBURG, GERMANY D 14770 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDE
ROSNER-MAUTBY MEDITRADE(THAILAND) 510(k) NO: K040448(TRADITIONAL)
ATTN: HO WENG FATT PHONE NO : 667 437 0199
199 MOO 11, TAMBON BANPRU SE DECISION MADE: 23-MAR-04
HATYAI, SONGKHLA, THAILAND 90250 510(k) STATEMENT
DEVICE: SP NEWTRON MODULE
SATELEC 510(k) NO: K033764(TRADITIONAL)
ATTN: PASCAL DUPEYRON PHONE NO : 011 335 56340607
Z.I. DU PHARE, BP 216 SE DECISION MADE: 01-MAR-04
17,AVENUE GUSTAVE EIFFEL 510(k) SUMMARY AVAILABLE FROM FDA
MERIGNAC CEDEX, FRANCE 33708
DEVICE: ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS
SCIENT'X 510(k) NO: K033109(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 23-MAR-04
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLO-SURPLUSP.A.D.
SCION CARDIO-VASCULAR, INC. 510(k) NO: K032986(TRADITIONAL)
ATTN: RAMON AUGUSTO PAZ PHONE NO : 305-259-8880
14256 SW 119 AVE. SE DECISION MADE: 01-MAR-04
MIAMI, FL 33186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFILE 1320 LASER SYSTEM
SCITON, INC. 510(k) NO: K032459(TRADITIONAL)
ATTN: JAY M PATEL PHONE NO : 650-493-9155
845 COMMERCIAL ST. SE DECISION MADE: 09-MAR-04
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFILE 2000/3000 LASER SYSTEM
SCITON, INC. 510(k) NO: K040005(TRADITIONAL)
ATTN: JAY M PATEL PHONE NO : 650-493-9155
845 COMMERCIAL AVE. SE DECISION MADE: 29-MAR-04
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANTERIOR LUMBAR BUTTRESS SYSTEM
SEASPINE 510(k) NO: K040130(TRADITIONAL)
ATTN: DIANA SMITH PHONE NO : 619-251-9132
727 PARK BLVD. SE DECISION MADE: 26-MAR-04
SAN DIEGO, CA 92101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE
SECTRA AB 510(k) NO: K034059(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 214-262-4209
1100 LAKEVIEW BLVD. SE DECISION MADE: 09-MAR-04
DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIOX80 AEROSOL ADAPTER
SENSORMEDICS CORP. 510(k) NO: K032516(TRADITIONAL)
ATTN: PAUL L KITTINGER PHONE NO : 714-283-2228
22705 SAVI RANCH PKWY. SE DECISION MADE: 04-MAR-04
YORBA LINDA, CA 92887-4645 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERRALAPG
SERRAL, S.A. DE C.V. 510(k) NO: K033762(TRADITIONAL)
ATTN: SCOTT HENDERSON PHONE NO : 757-561-9772
5251-18 JOHN TYLER HWY, SE DECISION MADE: 15-MAR-04
SUITE 167 510(k) STATEMENT
WILLIAMSBURG, VA 23185
DEVICE: DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
SHANGHAI PALOMAR MOUNTAIN INDUSTRI510(k) NO: K031142(TRADITIONAL)
ATTN: DANNY WANG PHONE NO : 862 157 727722
#1 BIYU RD., CANGQIAO TOWNSHIP SE DECISION MADE: 17-MAR-04
SONGJIANG SHANGHAI, CHINA 201600 510(k) STATEMENT
DEVICE: MANUAL WHEELCHAIRS SERIES
SHANGHAI WHEELCHAIR FACTORY 510(k) NO: K040561(TRADITIONAL)
ATTN: TRACY MA PHONE NO : 877-836-3673
120 IONIA STREET SW SE DECISION MADE: 31-MAR-04
SUITE 102 510(k) SUMMARY AVAILABLE FROM FDA
GRAND RAPIDS, MI 49503
DEVICE: PM-8000 PATIENT MONITOR, MODEL 8000
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K032733(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 03-MAR-04
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEI
SHUN THAI RUBBER GLOVES INDUSTRY P510(k) NO: K040408(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 17-MAR-04
SPARKS, NV 89434 510(k) STATEMENT
DEVICE: SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALI
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K024213(TRADITIONAL)
ATTN: JAMIE YIEH PHONE NO : 908-227-8807
186 S. WOOD AVENUE SE DECISION MADE: 23-MAR-04
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K040502(TRADITIONAL)
ATTN: PATRICK J LYNCH PHONE NO : 425-557-1825
22010 S.E. 51ST ST. SE DECISION MADE: 09-MAR-04
ISSAQUAH, WA 98029-7002 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SIREMOBIL ISO-C 3D
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K040347(TRADITIONAL)
ATTN: NEALIE HARTMAN PHONE NO : 610-448-1769
51 VALLEY STREAM PARKWAY SE DECISION MADE: 09-MAR-04
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM PROJECT P30L
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K040577(SPECIAL)
ATTN: NEALIE HARTMAN PHONE NO : 610-448-1769
51 VALLEY STREAM PARKWAY SE DECISION MADE: 22-MAR-04
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLONOSIGHT MODEL 510B
SIGHTLINE TECHNOLOGIES LTD. 510(k) NO: K032688(TRADITIONAL)
ATTN: SHARON GOLDFARB-ALBAK PHONE NO : 972 485 50447
MATAM - BLDG. 20 SE DECISION MADE: 05-MAR-04
HAIFA, ISRAEL 31905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINON POWER WHEELCHAIR, SN-P401
SINON CORPORATION 510(k) NO: K040320(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 12-MAR-04
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
SMITH & NEPHEW, INC. 510(k) NO: K034012(TRADITIONAL)
ATTN: KAREN PROVENCHER PHONE NO : 978-749-1365
150 MINUTEMAN RD. SE DECISION MADE: 16-MAR-04
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIGEN TROCHANTERIC ANTEGRADE NAIL
SMITH & NEPHEW, INC. 510(k) NO: K040462(SPECIAL)
ATTN: KIM KELLY PHONE NO : 901-399-6566
1450 E. BROOKS RD. SE DECISION MADE: 23-MAR-04
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOHNIKS
SOHNIKS ENDOSCOPY, INC. 510(k) NO: K033191(TRADITIONAL)
ATTN: MARC HOSKINS PHONE NO : 651-452-4059
930 BLUE GENTIAN RD. SE DECISION MADE: 09-MAR-04
SUITE 1400 510(k) SUMMARY AVAILABLE FROM FDA
EAGAN, MN 55121
DEVICE: CORRESTORE PATCH SYSTEM
SOMANETICS CORP. 510(k) NO: K040162(TRADITIONAL)
ATTN: RONALD A WIDMAN PHONE NO : 248-689-3050
1653 EAST MAPLE RD. SE DECISION MADE: 16-MAR-04
TROY, MI 48083-4208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHIRAZ POSTERIOR SYSTEM
SPINE NEXT AMERICA 510(k) NO: K033947(TRADITIONAL)
ATTN: DIANE JOHNSON PHONE NO : 410-409-8276
104 GREENWOOD CREEK ROAD SE DECISION MADE: 04-MAR-04
QUEENSTOWN, MD 21658 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHIRAZ-ANTERIOR SYSTEM
SPINE NEXT AMERICA 510(k) NO: K033965(TRADITIONAL)
ATTN: DIANE JOHNSON PHONE NO : 410-409-8276
104 GREENWOOD CREEK ROAD SE DECISION MADE: 04-MAR-04
QUEENSTOWN, MD 21658 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUREX FLAVORED LATEX CONDOM
SSL AMERICAS, INC. 510(k) NO: K032227(ABBREVIATED)
ATTN: KATHLEEN HARRIS PHONE NO : 770-582-2154
3585 ENGINEERING DR. SE DECISION MADE: 29-MAR-04
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092
DEVICE: FLIGHT SOCK
SSL AMERICAS, INC. 510(k) NO: K040353(TRADITIONAL)
ATTN: KATHLEEN J HARRIS PHONE NO : 770-582-2152
3585 ENGINEERING DR. SE DECISION MADE: 11-MAR-04
NORCROSS, GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL
STANBIO LABORATORY 510(k) NO: K032932(TRADITIONAL)
ATTN: ADAOBI OGUCHI PHONE NO : 830-249-0772
1261 NORTH MAIN ST. SE DECISION MADE: 10-MAR-04
BOERNE, TX 78006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL C
STANBIO LABORATORY 510(k) NO: K032936(TRADITIONAL)
ATTN: ADAOBI OGUCHI PHONE NO : 830-249-0772
1261 NORTH MAIN ST. SE DECISION MADE: 12-MAR-04
BOERNE, TX 78006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTUM LIGHT THERAPY SYSTEM
STARGATE INTERNATIONAL, INC. 510(k) NO: K032816(TRADITIONAL)
ATTN: ROBERT H WALKER PHONE NO : 303-840-8206
10235 SOUTH PROGRESS WAY # 7 SE DECISION MADE: 26-MAR-04
PARKER, CO 80134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
STELKAST COMPANY 510(k) NO: K033944(TRADITIONAL)
ATTN: DONALD A STEVENS PHONE NO : 724-941-6368
200 HIDDEN VALLEY RD. SE DECISION MADE: 12-MAR-04
MCMURRAY, PA 15317 510(k) STATEMENT
DEVICE: A1C-CHEX
STRECK LABORATORIES, INC. 510(k) NO: K040025(TRADITIONAL)
ATTN: KERRIE OETTER PHONE NO : 402-537-5215
7002 SOUTH 109TH ST. SE DECISION MADE: 02-MAR-04
LA VISTA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
STRYKER INSTRUMENTS 510(k) NO: K040300(TRADITIONAL)
ATTN: JEAN W SHEPPARD PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 03-MAR-04
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM
STRYKER LEIBINGER 510(k) NO: K040022(TRADITIONAL)
ATTN: WADE T RUTKOSKIE PHONE NO : 269-323-4226
4100 EAST MILHAM AVE. SE DECISION MADE: 12-MAR-04
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIZM KERATOME BLADE, MODEL MK8512M2
SURGIN SURGICAL INSTRUMENTATION, I510(k) NO: K033236(TRADITIONAL)
ATTN: DON HAAR PHONE NO : 714-832-6300
14762 BENTLEY CIRCLE SE DECISION MADE: 26-MAR-04
TUSTIN, CA 92680 510(k) STATEMENT
DEVICE: STEERABLE STYLET
SYNOVIS SURGICAL INNOVATIONS 510(k) NO: K040001(TRADITIONAL)
ATTN: JAMES JENKINS PHONE NO : 651-603-5229
2575 UNIVERSITY AVE. SE DECISION MADE: 09-MAR-04
ST. PAUL, MN 55114-1024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI
SYNOVIS SURGICAL INNOVATIONS 510(k) NO: K040119(TRADITIONAL)
ATTN: ANGELA MALLERY PHONE NO : 651-796-7372
2575 UNIVERSITY AVE. SE DECISION MADE: 17-MAR-04
ST. PAUL, MN 55114-1024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES VENTROFIX MIS SYSTEM
SYNTHES (USA) 510(k) NO: K031100(TRADITIONAL)
ATTN: JOHN WALSH PHONE NO : 484-356-9621
1380 ENTERPRISE DR. SE DECISION MADE: 04-MAR-04
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM
SYNTHES (USA) 510(k) NO: K033816(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 02-MAR-04
POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS
SYNTHES (USA) 510(k) NO: K033975(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 01-MAR-04
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3.5 MM LCP DISTAL HUMERUS SYSTEM
SYNTHES (USA) 510(k) NO: K033995(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 01-MAR-04
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES EXTERNAL MIDFACE DISTRACTOR
SYNTHES (USA) 510(k) NO: K040083(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 31-MAR-04
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE
SYNTHES (USA) 510(k) NO: K040258(TRADITIONAL)
ATTN: ANGELA SILVESTRI PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 23-MAR-04
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, X
SYSMEX AMERICA, INC. 510(k) NO: K040073(TRADITIONAL)
ATTN: NINA GAMPERLING PHONE NO : 847-996-4675
ONE NELSON C. WHITE PARKWAY SE DECISION MADE: 18-MAR-04
MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H
TAGA MEDICAL TECHNOLOGIES, INC. 510(k) NO: K040507(TRADITIONAL)
ATTN: GARY AUSTIN PHONE NO : 440-602-8242
34675 VOKES DR. SE DECISION MADE: 04-MAR-04
SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA
EASTLAKE, OH 44095
DEVICE: FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL
TELEFLEX MEDICAL 510(k) NO: K040472(SPECIAL)
ATTN: ANGELA TRAN PHONE NO : 919-361-4008
2917 WECK DRIVE SE DECISION MADE: 15-MAR-04
RESEARCH TRIANGLE PARK, NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPIOX FLEXIBLE VENOUS RESERVOIR
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K040023(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL RD. SE DECISION MADE: 01-MAR-04
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR
TERUMO CORP. 510(k) NO: K040210(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL RD. SE DECISION MADE: 03-MAR-04
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROGREAT
TERUMO MEDICAL CORP. 510(k) NO: K033913(TRADITIONAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7213
125 BLUE BALL RD. SE DECISION MADE: 11-MAR-04
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERUMO SURGUARD2 SAFETY NEEDLE
TERUMO MEDICAL CORP. 510(k) NO: K040531(SPECIAL)
ATTN: BARBARA SMITH PHONE NO : 410-392-7241
125 BLUE BALL RD. SE DECISION MADE: 23-MAR-04
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANSPACH "ADVANCED MICRO SAW ATTACHMENTS"
THE ANSPACH EFFORT, INC. 510(k) NO: K040076(TRADITIONAL)
ATTN: WILLIAM G CONETY PHONE NO : 561-627-1080
4500 RIVERSIDE DR. SE DECISION MADE: 15-MAR-04
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREELITE HUMAN KAPPA AND LAMBDA KITS
THE BINDING SITE, LTD. 510(k) NO: K040009(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 11-MAR-04
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: EL-ANA PROFILES: ANTI-CHROMATIN
THERATEST LABORATORIES, INC. 510(k) NO: K040291(TRADITIONAL)
ATTN: MARIUS TEODORESCU PHONE NO : 630-627-6069
1111 N. MAIN ST. SE DECISION MADE: 11-MAR-04
LOMBARD, IL 60148 510(k) STATEMENT
DEVICE: THERILINK BONE VOID FILLER
THERICS, INC. 510(k) NO: K040134(SPECIAL)
ATTN: JOHNATHAN S KAHAN PHONE NO : 202-637-5794
555 13TH STREET, NW SE DECISION MADE: 09-MAR-04
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CT OIA
THERMO BIOSTAR, INC. 510(k) NO: K032330(TRADITIONAL)
ATTN: JOHN G ADAMS PHONE NO : 303-530-3888
331 SOUTH 104TH ST. SE DECISION MADE: 02-MAR-04
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPI CONTACT DENTAL IMPLANT
THOMMEN MEDICAL, AG 510(k) NO: K034014(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON RD. SE DECISION MADE: 05-MAR-04
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TH0R DDII IR LAMP SYSTEM
THOR INTL. 510(k) NO: K033923(TRADITIONAL)
ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433
12101 CULLEN BLVD #A SE DECISION MADE: 17-MAR-04
HOUSTON, TX 77047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 A
TIARA MEDICAL SYSTEMS, INC. 510(k) NO: K031935(TRADITIONAL)
ATTN: GEOFFREY SLEEPER PHONE NO : 216-521-1220
14414 DETROIT AVE, SUITE 205 SE DECISION MADE: 03-MAR-04
LAKEWOOD, OH 44107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMORRHAGE OCCLUDER PIN
TOOLS FOR SURGERY, LLC 510(k) NO: K040109(TRADITIONAL)
ATTN: ARNOLD R LEIBOFF PHONE NO : 631-751-6930
1339 STONY BROOK ROAD SE DECISION MADE: 25-MAR-04
STONY BROOK, NY 11790 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY LOOP, MODEL EZL-01
TOOLS FOR SURGERY, LLC 510(k) NO: K040110(TRADITIONAL)
ATTN: ARNOLD R LEIBOFF PHONE NO : 631-751-6930
1339 STONY BROOK ROAD SE DECISION MADE: 24-MAR-04
STONY BROOK, NY 11790 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE
TRI-MED, INC. 510(k) NO: K040112(TRADITIONAL)
ATTN: ROBERT J MEDOFF PHONE NO : 808-782-2123
25768 PARADA DR. SE DECISION MADE: 12-MAR-04
VALENCIA, CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONE-LOK HP WASHER
TRIAGE MEDICAL INC 510(k) NO: K040250(TRADITIONAL)
ATTN: GAYLE HIROTA PHONE NO : 949-472-0006
13700 ALTON PKWY. SE DECISION MADE: 23-MAR-04
SUITE 160 510(k) SUMMARY AVAILABLE FROM FDA
IRVINE, CA 92618
DEVICE: ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM
ULTIMATE CONCEPTS, INC. 510(k) NO: K033149(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 23-MAR-04
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WBR-FHR, WBR-FWB
ULTRASPECT LTD. 510(k) NO: K040370(SPECIAL)
ATTN: DAN LAOR PHONE NO : 972 485 46611
BUILDING # 30 MATAM SE DECISION MADE: 11-MAR-04
HAIFA, ISRAEL 31905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO E.P.T. PREGNANCY TEST
UNIPATH LTD. 510(k) NO: K040329(SPECIAL)
ATTN: LOUISE ROBERTS PHONE NO : 44 123 4835564
PRIORY BUSINESS PARK SE DECISION MADE: 08-MAR-04
BEDFORD, UNITED KINGDOM MK44 3UP 510(k) STATEMENT
DEVICE: CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST
UNIPATH LTD. 510(k) NO: K040341(SPECIAL)
ATTN: LOUISE ROBERTS PHONE NO : 44 123 4835564
PRIORY BUSINESS PARK SE DECISION MADE: 08-MAR-04
BEDFORD, UNITED KINGDOM MK44 3UP 510(k) STATEMENT
DEVICE: HERCULON SOFT TISSUE REATTACHMENT SYSTEM
UNITED STATES SURGICAL, A DIVISION510(k) NO: K040594(SPECIAL)
ATTN: CHESTER MCCOY PHONE NO : 203-845-1390
150 GLOVER AVE. SE DECISION MADE: 31-MAR-04
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHAPE LOCKING ENDOSCOPIC OVERTUBE
USGI MEDICAL, INC. 510(k) NO: K033954(TRADITIONAL)
ATTN: JEFFREY A ANDERSON PHONE NO : 949-633-5067
1140 CALLE CORDILLERA SE DECISION MADE: 19-MAR-04
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K040541(SPECIAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 22-MAR-04
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PAD
VASCULAR SOLUTIONS, INC. 510(k) NO: K040510(TRADITIONAL)
ATTN: GREGORY M SACHS PHONE NO : 763-656-4250
6464 SYCAMORE COURT NORTH SE DECISION MADE: 17-MAR-04
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY
VASOMEDICAL, INC. 510(k) NO: K033617(TRADITIONAL)
ATTN: THOMAS R VARRICCHIONE PHONE NO : 516-997-4600
180 LINDEN AVE. SE DECISION MADE: 01-MAR-04
WESTBURY, NY 11590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEV
VERNON-CARUS LIMITED 510(k) NO: K033842(TRADITIONAL)
ATTN: C. ROBERT PAYNE, JR., P.E. PHONE NO : 408-782-3024
SE DECISION MADE: 04-MAR-04
510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTEBRON SCP CERVICAL PLATE SYSTEM
VERTEBRON, INC. 510(k) NO: K040003(TRADITIONAL)
ATTN: BRUCE KHALILI PHONE NO : 203-380-9340
136 ALBERT AVENUE SE DECISION MADE: 26-MAR-04
STRATFORD, CT 06614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDAPORT INTRAOSSEOUS INFUSION SYSTEM
VIDACARE CORPORATION 510(k) NO: K032885(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 10-MAR-04
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ22177
VILEX, INC. 510(k) NO: K023684(TRADITIONAL)
ATTN: ABRAHAM LAVI PHONE NO : 412-655-7550
345 OLD CURRY HOLLOW RD. SE DECISION MADE: 01-MAR-04
PLEASANT HILLS, PA 15236 510(k) STATEMENT
DEVICE: VIVARING MICROWAVE ABLATION PROBE
VIVANT MEDICAL, INC. 510(k) NO: K040279(SPECIAL)
ATTN: STEVEN KIM PHONE NO : 650-694-2900
1916-A OLD MIDDLEFIELD WAY SE DECISION MADE: 02-MAR-04
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET
WAKO CHEMICALS, USA, INC. 510(k) NO: K040226(TRADITIONAL)
ATTN: LORI CREASY PHONE NO : 877-714-1924
1600 BELLWOOD RD. SE DECISION MADE: 25-MAR-04
RICHMOND, VA 23237 510(k) STATEMENT
DEVICE: VITAL SIGNS MONITOR, PROPAQ LT
WELCH ALLYN PROTOCOL, INC. 510(k) NO: K033378(TRADITIONAL)
ATTN: DAVE KLEMENTOWSKI PHONE NO : 503-530-7500
8500 S.W. CREEKSIDE PLACE SE DECISION MADE: 01-MAR-04
BEAVERTON, OR 97008-7107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGE MANAGEMENT SYSTEM
WELCH ALLYN, INC. 510(k) NO: K033870(TRADITIONAL)
ATTN: DAVID KLEMENTOWSKI PHONE NO : 315-685-4133
4341 STATE ST. RD. SE DECISION MADE: 12-MAR-04
SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMIDUR SUPERIOR
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K040436(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 137050
SCHWENNINGER STRASSE 13 SE DECISION MADE: 05-MAR-04
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D
WIN-US TECHNOLOGY CO., LTD. 510(k) NO: K040691(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 770-777-4146
1308 MORNINGSIDE PARK DRIVE SE DECISION MADE: 23-MAR-04
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ALLOMATRIX MODEL# 86
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K020895(TRADITIONAL)
ATTN: ROGER D BROWN PHONE NO : 901-867-4457
5677 AIRLINE RD. SE DECISION MADE: 05-MAR-04
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATH FEMORAL STEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K034028(SPECIAL)
ATTN: JEANINE H REDDEN PHONE NO : 901-867-4522
5677 AIRLINE RD. SE DECISION MADE: 11-MAR-04
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOV
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K040503(SPECIAL)
ATTN: TERENCE LIM PHONE NO : 60 3 87061486
LOT1,JALAN3,KAWASAN PERUSAHAAN SE DECISION MADE: 16-MAR-04
BANDAR BARU SALAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA
SEPANG,SELANGOR DARUL EHSAN, MALAYSIA 43900
DEVICE: NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTA
YTY INDUSTRY (MANJUNG) SDN. BHD. 510(k) NO: K033887(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 02-MAR-04
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZAP HCG TEST, MODEL 8001
ZBX CORPORATION 510(k) NO: K033297(TRADITIONAL)
ATTN: TRACY YANG PHONE NO : 416 696 7208
42 LAIRD DRIVE SE DECISION MADE: 18-MAR-04
TORONTO, CANADA M4G 3T2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
ZEUS SCIENTIFIC, INC. 510(k) NO: K033977(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 22-MAR-04
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SEN
ZI BO HONG WANG PLASTIC & RUBBER P510(k) NO: K040532(TRADITIONAL)
ATTN: HUAN-CHUNG LI PHONE NO : 978-436-9980
17A STERLING ROAD SE DECISION MADE: 23-MAR-04
NORTH BILLERICA, MA 01862 510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 339
TOTAL WITH SUMMARIES 278
TOTAL WITH STATEMENTS 61
Updated 4/5/2004
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