FDA 510(k) Decisions During March, 1978  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K780098 03/02/1978 LIQUID OXYGEN UNIT, PORTABLE 73BYJ ANDONIAN CRYOGENICS, INC.
K780126 03/02/1978 DILATOR, VESSEL & INTRODUCER, SHEATH ARGON MEDICAL CORP.
K780303 03/30/1978 AUTO ISO-FILTER COLLECTION TUBE CAP BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780350 03/27/1978 I.V. START KIT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780253 03/28/1978 REAGENT SYSTEM, ARIA II T3 UPTAKE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780260 03/14/1978 TEMP. SENSOR W/22MM FITTINGS BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780229 03/02/1978 ABDOMINAL BELT BIOMET, INC.
K780227 03/15/1978 BANDAGE SPREADER BLOCK BIOMET, INC.
K780375 03/15/1978 PAVLIK HARNESS BIOMET, INC.
K780162 03/27/1978 DIGAPHOT PHOTOTHERAPY METER MODEL PT 145 CAVITRON CORP.
K780376 03/14/1978 MINIDENTOFLEX NEW POLISHING SYSTEM CAVITRON CORP.
K780377 03/14/1978 PINIDENTOFLEX DENTAL POLISHER CAVITRON CORP.
K780046 03/15/1978 ULTRASPHYG BLOOD PRESSURE OPTION CAVITRON CORP.
K780294 03/28/1978 G WRAP CEL-FIBE
K780265 03/09/1978 FLOW REDUCING ANGULATION STAND CHESEBROUGH-POND'S U.S.A. CO.
K780264 03/09/1978 NEBULIZATION KIT & ADAPTER KIT CHESEBROUGH-POND'S U.S.A. CO.
K780459 03/30/1978 CLEARTONE MODEL-1 & 2 HEARING AIDS CLEARTONE CUSTOM HEARING INSTRUMENTS
K772017 03/27/1978 IN VITRO THEOPHYLLINE RIA TEST CLINICAL ASSAYS, INC.
K780271 03/02/1978 COBE STOPCOCK COBE LABORATORIES, INC.
K780419 03/27/1978 SUBCLAVIAN TRAY CONCORD LABORATORIES, INC.
K780208 03/03/1978 ASPIRATOR, MANUEL DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K780281 03/02/1978 IMMUFUGE DISP. LINER DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K780047 03/02/1978 PLATELET AGGREGATING REAGENTS DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K780280 03/15/1978 BALLOON PUMP DATASCOPE CORP.
K780217 03/15/1978 ANTERIORS AND POSTERIORS, PLASTIC DENTSPLY INTL.
K780283 03/17/1978 INSERTER, PLUG, BONE, LIDGE DEPUY, INC.
K780284 03/15/1978 TIBIAL PLATEU DEPUY, INC.
K780329 03/17/1978 TOTAL HIP, NEW ENGLAND BAPTIST DEPUY, INC.
K780021 03/17/1978 URINE SCREENING KITS DIAGNOSTIC CULTURE SYSTEM
K780305 03/27/1978 CELL DYNATECH LABORATORIES, INC.
K780248 03/02/1978 CRONEX QC-1 PROCESSOR E.I. DUPONT DE NEMOURS & CO., INC.
K772373 03/09/1978 ANDERSON-NEIVERT OSTEOTOME EDWARD WECK, INC.
K772395 03/09/1978 DAVIS RHYTIDECTOMY EDWARD WECK, INC.
K772394 03/09/1978 KALRN FACE-LIFE SCISSORS EDWARD WECK, INC.
K772383 03/09/1978 LONG JEWELERS FORCEPS EDWARD WECK, INC.
K780154 03/17/1978 NEEDLEHOLDER, MICROVASULAR 5 1/2" EDWARD WECK, INC.
K772376 03/09/1978 NEIVERT OSTEOTOME EDWARD WECK, INC.
K772378 03/09/1978 NEIVS TRACHEOTOMY RETRACTOR EDWARD WECK, INC.
K772374 03/09/1978 SILVER OSTEOTOME EDWARD WECK, INC.
K780349 03/14/1978 VAGINAL RETRACTOR EDWARD WECK, INC.
K780238 03/15/1978 PACEMAKER, PROLITH 23U. PULSE GENERATOR EDWARDS PACEMAKER SYSTEMS
K780176 03/02/1978 DISPLAY SYSTEM MODEL 428 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K780177 03/02/1978 FETAL MONITOR MODEL 112 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K780285 03/30/1978 SOLUBLE COLLAGEN GENERAL DIAGNOSTICS
K780326 03/14/1978 GE CT/T 8800 SYSTEM GENERAL ELECTRIC CO.
K780306 03/17/1978 LYOPHILIZED VIALS OF VCA AND VCAT GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K780172 03/09/1978 TRIGLYCERIDE INSTRUMENT APPLICATION HARLECO
K780141 03/09/1978 ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI. HARLECO
K780100 03/09/1978 ULTRAZYME PLUS CK-1 HARLECO
K780099 03/09/1978 ULTRAZYME PLUS GT HARLECO
K780363 03/21/1978 PHONIC EAR HC ELECTRONICS
K780256 03/28/1978 HDL CHOLESTEROL METHOD HELENA LABORATORIES
K780324 03/14/1978 CAPNOMETER MODEL 47210A HEWLETT-PACKARD CO.
K780332 03/22/1978 CATHODE RAY TUBE DISPLAY MODEL 1340A HEWLETT-PACKARD CO.
K780428 03/30/1978 ROCHE TSH RIA HOFFMANN-LA ROCHE, INC.
K780125 03/15/1978 FLUORESOFT HOLLES LABORATORIES, INC.
K780320 03/17/1978 PASSIVE TENDON IMPLANT HOLTER-HAUSNER INTL.
K780322 03/14/1978 ANALYZER, PULMONARY FUNCTION HOSPAL MEDICAL CORP.
K780187 03/15/1978 NAIL, MASSIE II HOWMEDICA CORP.
K780317 03/06/1978 TOTAL HIP SYSTEM, HARRIS HD2 HOWMEDICA CORP.
K780216 03/14/1978 LIFESAVER, MANUAL #5160 HUDSON OXYGEN THERAPY SALES CO.
K780204 03/03/1978 CHEMISTRY CONTROL & REFERENCE SERUMS HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K780335 03/22/1978 LAS-R HUMAN C1 ESTERASE INHIBITOR TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K780203 03/27/1978 THROMBOPLASTIN DRIED HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K770527 03/17/1978 CANDIDA IMMUNODIFFUSION KIT I M, INC.
K780325 03/17/1978 RID SYSTEM-HUMAN C-REACTIVE PROTEIN ICL SCIENTIFIC
K772350 03/09/1978 PATIENT ALERT MODEL 555 INTERMEDICS, INC.
K780155 03/02/1978 DUAL CHANNEL PULSE HEIGHT ANALYZER ISO GRAPHICS, INC.
K772308 03/03/1978 AUTOZYME GLUCOSE OXIDASE (TRINDER) J.T. BAKER CHEMICAL CO.
K780083 03/09/1978 ANALYZER, SELECTIVE, ELECTRONIC JOHNS SCIENTIFIC, INC.
K780323 03/17/1978 QUANTITOPE 125-I GENTAMICIN RIA KIT KALLESTAD LABORATORIES, INC.
K780408 03/22/1978 MICRONET LIGHT DRESSING SPONGE KENDALL RESEARCH CENTER
K780090 03/14/1978 DENTAL ALLOY KRUPP INTERNATIONAL, INC.
K780201 03/02/1978 SPEAKER-AMPLIFIER & RECORDER INTERFACE L&M ULTRASCOPE LIFE MONITORING SYS.
K780200 03/02/1978 ULTRASCOPE L&M ULTRASCOPE LIFE MONITORING SYS.
K780384 03/15/1978 IMPROVED DYCAL L.D. CAULK CO.
K772277 03/02/1978 BLADDER RETENTION-CATHETHERIZATIONTRAY LATEX IND., INC.
K780338 03/15/1978 MINYSTAG MN-1 LKB INSTRUMENTS, INC.
K780382 03/14/1978 AUDIOMETER, PORTABLE, AIR CONDUCTION MAICO HEARING INSTRUMENTS, INC.
K772282 03/09/1978 HODGE TUBE MALLINCKRODT CRITICAL CARE
K780222 03/28/1978 I.V. START KIT MARION LABORATORIES, INC.
K780346 03/22/1978 MIF PROCEDURE KIT MARION LABORATORIES, INC.
K772276 03/14/1978 RAISED TOILET SEAT MEDFUSION SYSTEMS, INC.
K772275 03/14/1978 TOILET SAFETY RAIL MEDFUSION SYSTEMS, INC.
K780369 03/14/1978 MODUMED MUGE MEDTRONIC VASCULAR
K780368 03/14/1978 MODUMED MUGX MEDTRONIC VASCULAR
K780186 03/02/1978 NEUROMOD STIMULATOR MODEL 3723 MEDTRONIC VASCULAR
K780158 03/21/1978 TELETRACE TELEPHONE EKG TRANSMITTER MEDTRONIC VASCULAR
K780035 03/06/1978 MINIVISOR METRIX TEKNIKA, INC.
K780383 03/22/1978 COUNTER, RADIOASSAY, AUTO., MICROMEDIC MICROMEDIC SYSTEMS
K780163 03/27/1978 REDI-DISC HEMOGLOBIN GEL TUBE KIT MILES LABORATORIES, INC.
K780361 03/22/1978 T3 UPTAKE TEST MONOBIND
K780396 03/22/1978 NASAL GASTRIC TUBE RETAINER MOR-MAC, INC.
K780400 03/27/1978 DEN-Z-ORB NICE-PAK PRODUCTS, INC.
K780423 03/30/1978 STIKSEP-T4 RIA KIT NUCLEAR DIAGNOSTICS, INC.
K780292 03/02/1978 TRIA-PEG RIA DIAG. KIT NUCLEAR DIAGNOSTICS, INC.
K780165 03/02/1978 PROCESSOR, VIDEO IMAGE VIP-550 OHIO NUCLEAR, INC.
K780239 03/15/1978 BRACKET, METAL REINFORCED PLASTIC ORMCO CORP.
K780398 03/21/1978 CUP, ACETABULAR, LONG POSTERIOR WALL ORTHOPEDIC EQUIPMENT CO., INC.
K780397 03/22/1978 ORTHOPEDIC FORCEPS ORTHOPEDIC EQUIPMENT CO., INC.
K780195 03/09/1978 WHEELCHAIR MUFF ORTHOPEDIC EQUIPMENT CO., INC.
K780237 03/09/1978 DISPOSABLE CONTROLLED DROP PASTEUR PIPET OWENS-ILLINOIS, INC.
K780316 03/17/1978 RABBIT ANTIBODY TO DIGOXIN PCL-RIA, INC.
K780278 03/02/1978 RADIATION THERAPY TREAT. PLAN. SYS. PFIZER MEDICAL SYSTEMS, INC.
K780313 03/14/1978 HITACHI TECH-MOBLE DHC-121 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K780319 03/14/1978 ORBITOME-UG PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K780243 03/02/1978 TAMPON, RELY MODIFIED PROCTER & GAMBLE MFG. CO.
K780404 03/28/1978 ECG MONITORING SYSTEM, QUINTON, INC.
K780399 03/17/1978 INSTRUMENT CLEANING BRUSH RANSOM AND RANDOLPH
K772290 03/15/1978 DIALYZER, CAPILATORY, HOLLOW FIBER REDY LABORATORIES
K780148 03/03/1978 RIA FOR FOLATES & VIT. B12, COMBO KIT RIA PRODUCTS, INC.
K780254 03/09/1978 DENTURE CLEANSER & TOOTHPASTE IN ONE RICHARDSON MERREL, INC.
K780293 03/14/1978 ELECTROSURGICAL UNIT RITTER CO.
K780334 03/28/1978 ADHESIVE, BRACKET AND CONDITIONER RESIN ROCKY MOUNTAIN ORTHODONTICS, INC.
K780170 03/15/1978 ORTHODONTIC BRACKET PADS ROCKY MOUNTAIN ORTHODONTICS, INC.
K772117 03/02/1978 HEAT EXCHANGER, DISP., OMNITHERM SCIMED LIFE SYSTEMS, INC.
K780185 03/17/1978 OXYGEN ANALYZER 110 SIEMENS CORP.
K772298 03/02/1978 SEXUAL ASSAULT FORENCIC EVIDENCE KIT SIMPSON/BASYE, INC.
K780364 03/30/1978 MANIFOLD KIT SPICA, INC.
K780365 03/30/1978 OXYGEN/NITROUS OXIDE OUTLET SPICA, INC.
K780110 03/03/1978 CSF TOTAL PROTEIN TEST SET #0340 STANBIO LABORATORY
K780140 03/27/1978 CELL-CHEX STRECK LABORATORIES, INC.
K780219 03/03/1978 ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY SYVA CO.
K780388 03/22/1978 ANALYZER, 100, BICHROMATIC, ABBOTT SYVA CO.
K780218 03/03/1978 ANALYZER, EMIT AED ASSAYS TO CENTRIFICHE SYVA CO.
K780121 03/17/1978 REAGENTS, MANUEAL, ASSAY, THYROXINE SYVA CO.
K772362 03/17/1978 AVF SET FOR SINGLE NEEDLE HEMODIALYSIS TERUMO AMERICA, INC.
K780333 03/09/1978 GAS CHROMATOGRAPHY HEAD SPACE SAMP. HS6 THE PERKIN-ELMER CORP.
K780242 03/27/1978 SPECTROPHOTOMETER, FLUORESCENCE M.650-10 THE PERKIN-ELMER CORP.
K780474 03/30/1978 AUDIOMETER CALIBRATOR MODEL RA 310 TRACOR INSTRUMENTS, INC.
K780450 03/30/1978 TRACOR RA 410 AUDIOMETER TRACOR INSTRUMENTS, INC.
K780081 03/31/1978 DIALYZING FLUIDE DELIVERY SYSTEM TRAVENOL LABORATORIES, S.A.
K780189 03/30/1978 PLATELET ROTATOR TRAVENOL LABORATORIES, S.A.
K780164 03/15/1978 RTV DENTAL SILICONE TYDONT, INC.
K780395 03/31/1978 IMAGER, BODY SECTION, RADIONUCLIDE UNION CARBIDE CORP.
K780362 03/22/1978 SPECTROFLUOROMETER SF-330 VARIAN ASSOC., INC.
K780390 03/22/1978 SPECTROPHOTOMETER, ABSORPTION, ATOMIC VARIAN ASSOC., INC.
K780328 03/14/1978 PULMONARY FUNCTION TESTER, COMPUTERIZED WARREN E. COLLINS, INC.
K780245 03/27/1978 RECORDER, RE-100P HOT STYLUS STRIP CHART WATERS ASSOC., INC.
K780096 03/03/1978 LDH ISOENZYME CONTROL SERUM WORTHINGTON BIOCHEMICAL CORP.


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