FDA 510(k) Decisions During March, 1979  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K790246 03/02/1979 SARNS WIRE-REINFORCED VENOUS RETURN CAN 3M HEALTH CARE, SARNS
K790273 03/21/1979 MAMMOGRAPHY SYSTEM AND CASSETTE AGFA-GEVAERT, INC.
K790154 03/07/1979 MANIFOLD, FOR DOUBLE SUPPLY AIRLIFE, INC.
K790152 03/07/1979 MANIFOLD, UNIVERSAL I.P.P.B AIRLIFE, INC.
K790153 03/07/1979 MANIFOLD, W/CORRUGATED TUBING AIRLIFE, INC.
K790151 03/12/1979 ONE-WAY VALVE AIRLIFE, INC.
K790166 03/16/1979 OXYGEN MASK, ADULT VINYL AIRLIFE, INC.
K790213 03/22/1979 GENERATOR, R-WAVE AMR CO.
K790281 03/21/1979 DIAGNOSTIC SET, LIPO-FRAX ANALYTICAL PRODUCTS, INC.
K790405 03/26/1979 ANCHOR BRAND COUNT-TAINER ANCHOR PRODUCTS CO.
K790316 03/27/1979 ELECTRODE, ELECTROFLEX ANDOVER MEDICAL, INC.
K790328 03/02/1979 MODEL 1051, MONITOR APPLIED MEDICAL RESEARCH
K790468 03/19/1979 IMPLANTABLE HEART LEAD EXTENDER ARCO MEDICAL PRODUCTS CO.
K782129 03/12/1979 LUPO-TEC ARMKEL, LLC.
K790361 03/28/1979 RECIRCULATION FILTER MODEL RF-10 BENTLEY LABORATORIES, INC.
K790368 03/21/1979 MODIFIED THAYER MARTIN AGAR BIOMEDIA, INC.
K782032 03/02/1979 UNITEST AMYLASE BOEHRINGER MANNHEIM CORP.
K782156 03/02/1979 UNITEST CREATINE KINASE BOEHRINGER MANNHEIM CORP.
K790330 03/15/1979 CALBIOCHEM-BEHRING LASER IMMUNOGLOBULIN CALBIOCHEM-BEHRING CORP.
K790509 03/23/1979 CARDIOCASSETTE II, AMBULATORY ECG SYSTEM CAMBRIDGE INSTRUMENTS, INC.
K790566 03/19/1979 PACEMAKER, OVALITH-D CARDIAC CARATOMIC
K790432 03/20/1979 MICROLITH MODELS 505;605;507;607;703;803 CARDIAC PACEMAKERS, INC.
K790380 03/21/1979 LOW-TOX-H RABBIT COMPLEMENT CEDERLANE LABS LTD.
K790351 03/15/1979 RHEUMATELL CENTRAL BIOLOGICAL CO.
K790003 03/12/1979 RIA KIT, PROLACTIN CIS RADIOPHARMACEUTICALS, INC.
K790356 03/09/1979 OXYGENATOR, COBE CATALOG #42-220 COBE LABORATORIES, INC.
K782163 03/01/1979 THE BLUE MASK COLLECTOVAC, INC.
K790367 03/02/1979 GRAB-IT CONCEPT, INC.
K782021 03/21/1979 A.V. FISTULA NEEDLE SET CORDIS CORP.
K790294 03/21/1979 BUFFER, CORNING MOPSO CORNING MEDICAL & SCIENTIFIC
K790119 03/08/1979 C/N SCREEN CORNING MEDICAL & SCIENTIFIC
K790264 03/21/1979 DATA-TOPE TRI-RAC RADIOASSAY CONTROL DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K790204 03/12/1979 PLASMA, STANDARDIZED NORMAL DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K790404 03/21/1979 DTT SYSTEM DEPUY, INC.
K790459 03/28/1979 CEMENT DISPENSER CEMENT MIXER DOW CORNING WRIGHT
K790334 03/07/1979 DRAGER ORM DRAEGER MEDICAL, INC.
K790333 03/22/1979 NAD SCAVENGING RELIEF VALVE DRAEGER MEDICAL, INC.
K790103 03/12/1979 NEPHELOMETER, MIC-2000 LASER DYNATECH CORP.
K790088 03/12/1979 ACA CREATINE KINASE ISOENZYMES E.I. DUPONT DE NEMOURS & CO., INC.
K790413 03/16/1979 HEIFETZ ANEURYSM CLIP, LMM BLADE EDWARD WECK, INC.
K790203 03/02/1979 INTERVAL TIMER MODEL V4295 ELECTRONICS FOR MEDICINE, INC.
K790198 03/06/1979 MONITOR PLUG-IN MODEL M1106 ECG ELECTRONICS FOR MEDICINE, INC.
K790310 03/21/1979 HEMOGLOBIN CONTROLS ELECTROPHORESIS CORP.
K790311 03/21/1979 LDH ISOENZYME REAGENT ELECTROPHORESIS CORP.
K790499 03/26/1979 MULTIPLE PINHOLE TOMOGRAPHIC COLLIMOTER ENGINEERING DYNAMICS CORP.
K790466 03/28/1979 U-MAT ENGINEERING DYNAMICS CORP.
K790410 03/22/1979 ADULT ZEE-FRAME EQUILIBRATED BIO SYSTEMS, INC.
K790319 03/21/1979 ORTHO-TOLUIDINE REAGENT SET FISHER SCIENTIFIC CO., LLC.
K782128 03/02/1979 THERA CHEM FISHER SCIENTIFIC CO., LLC.
K790183 03/21/1979 PORTABLE WHEELCHAIR & CARRYING CASE FRED SAMMONS, INC.
K790285 03/08/1979 IMAGER, PHO/SONIC SERIES 2000 G.D. SEARLE AND CO.
K790418 03/21/1979 MODEL 8100 PRE-FILLED INTRAUTERINE GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K790323 03/21/1979 COAG-A-MATE 2001 GENERAL DIAGNOSTICS
K790392 03/26/1979 510 CARBINETTE X-RAY UNIT GENERAL X-RAY, INC.
K790511 03/26/1979 MOBILE X-RAY UNIT GENERAL X-RAY, INC.
K790443 03/26/1979 PORTABLE X-RAY UNIT GENERAL X-RAY, INC.
K790512 03/26/1979 PORTABLE X-RAY UNIT GENERAL X-RAY, INC.
K790393 03/26/1979 PORTABLE X-RAY UNIT, MATRIX S GX-101 GENERAL X-RAY, INC.
K790451 03/28/1979 X-RAY UNITS, GX-101, UCIS-510 AND GX-111 GENERAL X-RAY, INC.
K790375 03/15/1979 TRYPTIC SOY AGAR W/ 5% HORSE BLOOD GRANITE DIAGNOSTICS, INC.
K781901 03/06/1979 KANGA PANTS H.A. & J.E. WOOD, INC.
K790115 03/16/1979 BREATHING CIRCUIT, DISPOSABLE H.B. LABORATORIES, INC.
K790534 03/26/1979 MERSILENE SUTURES HANCOCK LABORATORIES, INC.
K790536 03/28/1979 CLEARVIEW HIPOINT RESEARCH, INC.
K790300 03/27/1979 META III HITTMAN MEDICAL SYSTEMS
K790267 03/21/1979 SENSI-TEX HOFFMANN-LA ROCHE, INC.
K790396 03/21/1979 ULTRASONIC DIAGNOSTIC SYSTEM HOFFREL INSTRUMENTS, INC.
K790001 03/06/1979 DIALYZER, MODEL F.M.D 150 HOSPAL MEDICAL CORP.
K790348 03/06/1979 ANAMETRIC TIBIAL COMPONENT METAL TRAY HOWMEDICA CORP.
K790274 03/26/1979 BG PROXIMAL FEMUR HOWMEDICA CORP.
K790350 03/06/1979 POSTERIOR CRUCIATE CONDYLAR TIBIAL HOWMEDICA CORP.
K790349 03/06/1979 TOTAL CONDYLAR KNEE PROSTHESIS HOWMEDICA CORP.
K790059 03/15/1979 PROACTIVATOR C3, C4 AND C3 ICL SCIENTIFIC
K790257 03/15/1979 SYSTEMIC LUPUS ICL SCIENTIFIC
K790108 03/06/1979 FILTERSET 0.22, I.V. PUMP IMED CORP.
K782164 03/08/1979 STIMULATOR, MODEL 1-600 ELECTRIC NERVR IPCO CORP.
K782081 03/21/1979 RIA SYSTEM, PARATHYROID HORMONE ISO-TEX DIAGNOSTICS
K790385 03/22/1979 KOTEX TUBE AND STICK TAMPON KIMBERLY-CLARK CORP.
K790167 03/21/1979 SUNLAMP KNEILSLY GROUP ENT.
K790109 03/16/1979 TELEMETRY, BIOMEDICAL LKC TECHNOLOGIES, INC.
K790527 03/22/1979 BURNETT-KETCHUM DYNAMIC HAND EXERCISER MADDAK, INC.
K790129 03/21/1979 SERUM PAK, HCG CONTROL MALLINCKRODT CRITICAL CARE
K782051 03/21/1979 DRAPES, DISPOSABLE SURGICAL MARCO MFG.
K790205 03/19/1979 ELECTROAPPLICATOR MODEL C-1 MCG, INC.
K790314 03/06/1979 FLUID ADMINISTRATION SETS, 15 MICRON MEDEX, INC.
K790455 03/23/1979 MICROFLUSH MEDEX, INC.
K781772 03/06/1979 CATHETER, TRANSLUMINAL BALLOON MEDI-TECH, INC.
K790106 03/15/1979 IIF-A-N-DNA TEST KIT MEDICA CORP.
K790279 03/06/1979 CATHETER, MMG LATEX EXTERNAL MEDICAL MARKETING GROUP TIMOTHY GOLDEN
K790389 03/26/1979 GAUZE & COTTON SPONGES MEDTECH INTL., INC.
K790467 03/26/1979 SURGICAL EYE SPONGE MEDTECH INTL., INC.
K790074 03/29/1979 MEDTRONIC MODEL 6971 MEDTRONIC VASCULAR
K790463 03/26/1979 MODU-SET COLLIMOTOR MEDTRONIC VASCULAR
K790252 03/15/1979 ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI MELOY LABORATORIES, INC.
K790011 03/02/1979 STIMULATOR, MENTOR 100 NERVE MENTOR CORP.
K790260 03/21/1979 NTSH AUTOPAK TEST DELIVERY SYSTEM MICROMEDIC SYSTEMS
K790035 03/23/1979 AMBU SUCTION BOOSTER NARCO AIR-SHIELDS
K790036 03/02/1979 DIGITAL BPM NARCO AIR-SHIELDS
K790137 03/06/1979 INFANT CARE SYSTEM NARCO AIR-SHIELDS
K790456 03/23/1979 SERIES 7000 NARCO MCKESSON CO.
K790472 03/26/1979 BURRON VENTED NEEDLE NATIONAL PATENT DEVELOPMENT CORP.
K790060 03/21/1979 NEEDLE II, BURRON FILTER NATIONAL PATENT DEVELOPMENT CORP.
K781973 03/21/1979 CARDIOPHONE NORTH AMERICAN MOTRONIC
K790358 03/21/1979 FLUID ADMINISTRATION CAT.#14-923 NORTON PERFORMANCE PLASTICS CORP.
K790133 03/02/1979 SPINSEP-FE59 NUCLEAR DIAGNOSTICS, INC.
K790138 03/12/1979 CHORIC-SHURE NUCLEAR MEDICAL LABORATORIES, INC.
K782055 03/21/1979 CREAM, SIGNA PARKER LABORATORIES, INC.
K790089 03/06/1979 TAPE MEASURE PFIZER, INC.
K790239 03/08/1979 PHYTOHAEMAGGLUTININ PHARMACIA FINE CHEMICALS
K782165 03/21/1979 PHASEAFILL PHASEALLOY
K790394 03/23/1979 DEFIBRILLATOR INTERAL PADDLE TEST LOAD PHYSIO-CONTROL CORP.
K790325 03/02/1979 REPRODENT PREMIER DENTAL PRODUCTS CO.
K790523 03/27/1979 ARGYLE ESOPHAGEAL STETHOSCOPE SHERWOOD MEDICAL INDUSTRIES
K790196 03/13/1979 MONOJECT ARTERIAL BLOOD SAMPLING DEVICE SHERWOOD MEDICAL INDUSTRIES
K790197 03/12/1979 REAGENT KIT, LANCER GLUCOSE SHERWOOD MEDICAL INDUSTRIES
K790425 03/28/1979 IONESCU-SHILEY COMPOSITE CONDUIT-PULMONI SHILEY, INC.
K790359 03/21/1979 HALOTHANE VAPORIZER 950, & ENFLURANE 951 SIEMENS CORP.
K790342 03/22/1979 SOMATOM SD SIEMENS CORP.
K790388 03/26/1979 MEVATRON 60 SIEMENS MEDICAL LABORATORIES, INC.
K790211 03/15/1979 DEHYDROGENOSE, GLUCOSE PHOSPHATE SIGMA CHEMICAL CO.
K790271 03/06/1979 TRAY AND BAG, CATHETERIZATION SNYDER LABORATORIES, INC.
K790272 03/06/1979 TRAY, URETHRAL CATHETERIZATION SNYDER LABORATORIES, INC.
K790345 03/21/1979 STIMTECH TENS ELECTRODE STIMULATION TECHNOLOGY, INC.
K782061 03/21/1979 SPINAL SURGERY INSTRUMENTATION STUART DRUG & SURGICAL SUPPLY, INC.
K790435 03/27/1979 INTERSEPT* BLOOD FILTER W/ TUBING BYPASS SURGIKOS, INC.
K790255 03/02/1979 EMIT AED ASSAYS 3500 COMPUTER DIRECTED SYVA CO.
K790303 03/19/1979 EMIT AUTO DIGOXIN ASSAY SYVA CO.
K790403 03/21/1979 EMIT QUINIDINE ASSAY SYVA CO.
K790256 03/02/1979 EMIT THEOPHYLLINE ASSAY SYVA CO.
K790402 03/15/1979 EMIT-QUINIDINE CONTROL SYVA CO.
K790092 03/12/1979 URIC ACID, BOUND ENZYME TECHNICON INSTRUMENTS CORP.
K790412 03/19/1979 MODEL 337E HEARING AID TELEX COMMUNICATIONS, INC.
K790354 03/06/1979 MODEL 342 HEARING AIDS TELEX COMMUNICATIONS, INC.
K790355 03/06/1979 MODEL 342D HEARING AIDS TELEX COMMUNICATIONS, INC.
K790370 03/28/1979 BUNN MODEL #40 LOW PRESSURE ALARM THE JOHN BUNN CO.
K790117 03/19/1979 AUTOSAMPLER, MODEL AS-40 THE PERKIN-ELMER CORP.
K790235 03/15/1979 SPECTROPHOTOMETER MODEL 3000 THE PERKIN-ELMER CORP.
K790236 03/15/1979 SPECTROPHOTOMETER MODEL 650-40 THE PERKIN-ELMER CORP.
K782009 03/02/1979 RIA KIT, PROGESTERONE THE UPJOHN CO.
K790223 03/26/1979 DIALYZER, CD-800 COIL TRAVENOL LABORATORIES, S.A.
K790346 03/21/1979 ACTIVATOR TRI-MED, INC.
K790277 03/16/1979 QUICK-CHECK UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K790395 03/28/1979 "VIDICAM" VIDEO REPROGRAPH VIDICAM
K790214 03/19/1979 MODIFIED JACKSON-REES CIRCUIT VITAL SIGNS, INC.
K790488 03/28/1979 INTERPLANTA SP TOTAL HIP PROSTHESIS WALDEMAR LINK GMBH & CO. KG
K790470 03/16/1979 "THE GUARDIAN" SPHYGMOMANOMETER WORLD BOOK ENCYCLOPEDIA, INC.
K790302 03/21/1979 PRESSURE MONITOR, MODEL 212 ZATEK


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