FDA 510(k) Applications Received During June, 1979

FDA 510(k) Number Submission Date Device Name Applicant Contact
K791056 06/08/1979 3M CEMENT REMOVER 3M COMPANY
K791176 06/25/1979 3M COLD/HOT WATER BAG AND WRAP 3M COMPANY
K791094 06/12/1979 3M ORTHOPEDIC CASTING TAPE 3M COMPANY
K791057 06/08/1979 CAST BRACE COMPONENTS 3M COMPANY
K791198 06/26/1979 BIBAG AB MEDETT PRODUKTER
K791196 06/26/1979 URIDROP AB MEDETT PRODUKTER
K791197 06/26/1979 URIDROP SPECIAL AB MEDETT PRODUKTER
K791133 06/18/1979 ABCOR CARIES DETECTOR MONITOR ABCOR, INC.
K791154 06/20/1979 THERMAL CONDITIONING SYSTEM ACUREX AEROTHERM
K791055 06/07/1979 ADAC TOMOGRAPHY OPTION ADAC LABORATORIES
K791042 06/05/1979 I.P.P.B. MANIFOLD & NEBULIZER, UNIVERSAL AIRLIFE, INC.
K791189 06/26/1979 ECHO CARDIOGRAM PAD ALIMED, INC.
K791182 06/25/1979 ACMI RIGI-FLEX NEPHORSCOPE AMERICAN CYSTOCOPE MAKERS, INC.
K791016 06/01/1979 ULTICARE 2500 TREATMENT CHAIR AMERICAN HEALTH CARE INDUSTRIES, INC.
K791159 06/21/1979 DINAMAP MODEL 855 APPLIED MEDICAL RESEARCH
K791147 06/18/1979 ARCO PROGAMMABLE PACEMAKER SYSTEM ARCO MEDICAL PRODUCTS CO.
K791165 06/25/1979 ARCOLITH 4000 ARCO MEDICAL PRODUCTS CO.
K791192 06/26/1979 AF/SYSTEM ARIEL
K791191 06/26/1979 THE GALASSIA SYSTEM ARIEL
K791105 06/13/1979 B & L OPHTHALMIC CHAIR BAUSCH & LOMB, INC.
K791104 06/13/1979 B & L OPHTHALMIC INSTRUMENT STAND BAUSCH & LOMB, INC.
K791031 06/04/1979 ABNORMAL PROTEIN ELECTROPHORESIS CONTROL BECKMAN INSTRUMENTS, INC.
K791077 06/12/1979 BECKMAN ELECTROPHORESIS OVEN/INCUBATOR BECKMAN INSTRUMENTS, INC.
K791141 06/18/1979 BILIRUBIN CALIBRATOR CONTROL BECKMAN INSTRUMENTS, INC.
K791030 06/04/1979 HEMOGLOBIN AF/SC ELECTROPHORESIS CONTROL BECKMAN INSTRUMENTS, INC.
K791029 06/04/1979 NORMAL PROTEIN ELECTROPHORESIS CONTROL BECKMAN INSTRUMENTS, INC.
K791064 06/11/1979 DUO TWO LAYER DENTURE CLEANSER BLOCK DRUG COMPANY, INC.
K791186 06/25/1979 MODEL BP-2000 TIME-CYCLED VENTILATOR BOURNS MEDICAL SYSTEMS, INC.
K791020 06/01/1979 FLUID ADMINISTRATION SET FA-3160 BURRON MEDICAL PRODUCTS, INC.
K791054 06/07/1979 HYPER CHEC, SPHYGMOMANOMETER ELECTRONIC C.R. BARD, INC.
K791047 06/06/1979 NERVE STIMULATOR, DIGITAL PERIPHERAL C.R. BARD, INC.
K791118 06/15/1979 HLA CONTROL SERA CALBIOCHEM-BEHRING CORP.
K791117 06/15/1979 RABBIT COMPLEMENT CALBIOCHEM-BEHRING CORP.
K791201 06/28/1979 SCINTISTRESS SYSTEM CAMBRIDGE INSTRUMENTS, INC.
K791051 06/06/1979 PROGESTERONE RADIOIMMUNOASSAY KIT CIS RADIOPHARMACEUTICALS, INC.
K791202 06/28/1979 RIA KIT FOR TRYPSIN CIS RADIOPHARMACEUTICALS, INC.
K791079 06/12/1979 GAMMADAB (125 1) FOLATE RADIOASSAY KIT CLINICAL ASSAYS, INC.
K791086 06/12/1979 CENTRY 2 SYSTEM #016, 103, 016, 104 COBE LABORATORIES, INC.
K791101 06/13/1979 DISPOSABLE PERFORATORS, JACOBS, HUDSON CODMAN & SHURTLEFF, INC.
K791096 06/12/1979 RADIOIMMUNOASSAY TEST SYSTEM CORNING MEDICAL & SCIENTIFIC
K791129 06/14/1979 PERMANENT LEAD INTRADUCER DAIG CORP.
K791137 06/18/1979 SINGLE USE MONOPOLAR HAND CONTROL PENCIL DAVOL, INC.
K791160 06/22/1979 DENTALEEN DENPAC CORP.
K791204 06/28/1979 MITER ENDOSTEAL BLADE IMPLANT DEPUY, INC.
K791167 06/25/1979 DEXIDE DISPOSABLE PREP PAD DEXIDE, INC.
K791166 06/25/1979 DEXIDE DISPOSABLE PREP SPONGE DEXIDE, INC.
K791168 06/25/1979 DEXIDE DISPOSABLE PREP STICK DEXIDE, INC.
K791169 06/25/1979 DEXIDE DISPOSABLE SWAB STICK DEXIDE, INC.
K791015 06/01/1979 "VOLUREX TM" DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP.
K791049 06/06/1979 SYNALON ROLLER BOTTLE DYNATECH LABORATORIES, INC.
K791052 06/06/1979 ENDOSCOPIC INSTRUMENT EDER INSTRUMENT CO, INC.
K791157 06/21/1979 360 HEMOCLIP APPLIERS EDWARD WECK, INC.
K791183 06/25/1979 SWAN-GANZ FLOW-DIRECTED CATHETER EDWARDS LIFESCIENCES, LLC. SALLY L MAHER
K791158 06/21/1979 STIMULATOR, ELECTRICAL NERVE ELECTREAT, INC.
K791058 06/08/1979 ANTIBODY TO HERPESVIRUS HOMINIS ELECTRO-NUCLEONICS LABORATORIES, INC.
K791092 06/12/1979 ESTERASE-CHLOROESTERASE, STAINING KIT EUREKA LABORATORIES, INC.
K791046 06/05/1979 ENDOTRACHEAL TUBES, LONG & SHORT TERM EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K791045 06/05/1979 MODEL GV-10 LANZ PRESSURE-VALVE EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K791044 06/05/1979 TRACHEOSTOMY TUBES, SHORT AND LONG TERM EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K791018 06/01/1979 FERMCOTEST R BUN RATE REAGENT TEST KIT FERMCO BIOCHEMICS, INC.
K791066 06/12/1979 GLUCOSE GOD-PAP TRINDER METHOD TEST KIT FERMCO BIOCHEMICS, INC.
K791200 06/28/1979 PRE-DENT FICHTE, GRAVES, AND HUNT
K791111 06/14/1979 AUTOMATED ELECTROPHORESES MACHINE GELMAN SCIENCES, INC.
K791108 06/14/1979 CONTEXT FILTER GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K791041 06/05/1979 HEMATRAK ABNORMAL RECOGNITION GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K791184 06/25/1979 BIOBRANE BRAND TEMPORARY WOUND DRESSING HALL-WOODROOF, INC.
K791139 06/18/1979 PREGELLED DISPOSABLE ECG ELECTRODES HAYES PRODUCTS, INC.
K791140 06/18/1979 PREGELLED DISPOSABLE EELCTRO. SERIES 600 HAYES PRODUCTS, INC.
K791144 06/18/1979 BUFFERIZER HELENA LABORATORIES
K791135 06/18/1979 LYOPHILIZED G-HB QUIK COLUMN CONTROL HELENA LABORATORIES
K791138 06/18/1979 5880 SERIES OF GAS CHROMATOGRAPHS HEWLETT-PACKARD CO.
K791206 06/29/1979 HCG RIA PREGNANCY TEST HOFFMANN-LA ROCHE, INC.
K791075 06/12/1979 H-H SLOTTED CATHETER-RESERVOIR HOLTER-HAUSNER INTL.
K791076 06/12/1979 H-H SLOTTED VENTRICULAR CATHETER HOLTER-HAUSNER INTL.
K791151 06/20/1979 ECG CHANNEL OF DIAGNOSTIC SYSTEM HONEYWELL, INC.
K791113 06/15/1979 LOW IONIC STRENGTH SOLUTION (LISS) HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K791128 06/18/1979 PTH RIA 200 INSTITUT NATIONAL DES RADIOELEMENTS
K791194 06/25/1979 BRAIN HEART INFUSION BROTH ISLE MEDIA AND STERILE PRODUCTS, INC.
K791292 06/25/1979 BRAIN HEART INFUSION WITH AGAR BROTH ISLE MEDIA AND STERILE PRODUCTS, INC.
K791291 06/25/1979 BRAIN HEART INFUSION WITH BROTH ISLE MEDIA AND STERILE PRODUCTS, INC.
K791193 06/25/1979 NUTRIENT BROTH ISLE MEDIA AND STERILE PRODUCTS, INC.
K791171 06/25/1979 TRYPTIC SOY BROTH ISLE MEDIA AND STERILE PRODUCTS, INC.
K791143 06/18/1979 SICKLE-CELL F TEST ISOLAB, INC.
K791103 06/13/1979 LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT LEECO DIAGNOSTICS, INC.
K791112 06/15/1979 LIBCO 1,2,3, EYEGLASS FRAMES LIBCO EYEWEAR, INC.
K791188 06/26/1979 CAM-10 BATTERY PACK (#7-001) LIFECARE SERVICES, INC.
K791033 06/05/1979 CAM-10 PVV PORTABLE VOLUME VENTILATOR LIFECARE SERVICES, INC.
K791119 06/15/1979 MACOMB NORMAL CONTROL SERUM MACOMB CHEMICAL CO.
K791170 06/25/1979 MIS AURAL ACOUSTIC SCREENER MAICO HEARING INSTRUMENTS, INC.
K791126 06/18/1979 MODEL CE-DM-II HEARING INSTRUMENT MARCON HEARING INSTRUMENTS, INC.
K791097 06/12/1979 CEPTORTRODE WITH CEPTOR HESIVE MED GENERAL
K791098 06/12/1979 SINGLE-USE MINI-BULLDOG MED GENERAL
K791095 06/12/1979 LITHICRON MODEL 0401, PACEMAKER MEDCOR, INC.
K791164 06/25/1979 NEGATOVE PRESSURE CONVERTOR MEDICORP, INC.
K791070 06/12/1979 ACCU-SORB STERILE STOCKINETTES MEDLINE INDUSTRIES, INC.
K791093 06/12/1979 MODELS 2411/2418 VENTRICULAR-INHIBITED MEDTRONIC VASCULAR
K791181 06/25/1979 PROGRAMMER, MEDTRONIC MODEL 5984/5985 MEDTRONIC VASCULAR
K791065 06/12/1979 IMMUNOSPOT TSH TEST MELOY LABORATORIES, INC.
K791190 06/26/1979 STETHOSCOPE WITH TEMPERATURE SENSOR NATIONAL CATHETER CO. DIV. MALLINCKRODT
K791150 06/15/1979 ELECTROENCEPHALOGRAPHS MODELS 7209,7213 NIHON KOHDEN AMERICA, INC.
K791233 06/29/1979 MODEL EEG-4214 ELECTROENCEPHALOGRAPH NIHON KOHDEN AMERICA, INC.
K791234 06/29/1979 MODEL EEG-4217 ELECTROENCEPHALOGRAPH NIHON KOHDEN AMERICA, INC.
K791149 06/15/1979 STIMULATOR MODEL SSS-1101 NIHON KOHDEN AMERICA, INC.
K791107 06/14/1979 STOPCOCK, THREE WAY NORTON PERFORMANCE PLASTICS CORP.
K791175 06/25/1979 ANALYZER, SODIUM/POTASSIUM NOVA BIOMEDICAL CORP.
K791152 06/19/1979 TCO2M MODEL 818 NOVAMETRIX MEDICAL SYSTEMS, INC.
K791195 06/26/1979 DELTASCAN COMPUTER TOMOGRAPHY X-RAY SCAN OHIO NUCLEAR, INC.
K791114 06/15/1979 BILI-DOSIMETER OLYMPIC MEDICAL CORP.
K791172 06/25/1979 OREIA-TU THYROID UPTAKER RATIO ASSAY ORGANON, INC.
K791013 06/01/1979 SPECTRA R PAD PARKER LABORATORIES, INC.
K791116 06/15/1979 PSORALITE SERIES 30,000 PAUL B. ELDER CO.
K791145 06/18/1979 CPR CONTROL SYSTEM PEPIN DISTRIBUTING, INC.
K791153 06/19/1979 ACTA-SCANNER 0220FS PFIZER, INC.
K791163 06/25/1979 PFIZER 0200FS LOCALLZER PFIZER, INC.
K791156 06/21/1979 AMIPAQUE MYELOGRAM TRAY PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K791062 06/08/1979 BOUNDARY SPECIALTY GOWN PROCTER & GAMBLE MFG. CO.
K791115 06/15/1979 GOAR ANTI-HUMAN LAMBODA CHAIN PROTOS LABORATORIES
K791178 06/25/1979 MYVACET 5-07, 7-00 AND 9-40 RADIATION PRODUCTS DESIGN, INC.
K791125 06/18/1979 PLUG-LOK CEMENT RESTIRCTOR RICHARD'S MEDICAL EQUIP., INC.
K791035 06/05/1979 FETASONDE FETAL ACTIVITY MONITOR ROCHE MEDICAL ELECTRONICS, INC.
K791039 06/05/1979 FETASONDE FETAL HEART RATE VARIABILITY ROCHE MEDICAL ELECTRONICS, INC.
K791037 06/05/1979 FETASONDE LABOR STATUS DISPLAY ROCHE MEDICAL ELECTRONICS, INC.
K791038 06/05/1979 FETASONDE UTERINE ACTIVITY MONITOR ROCHE MEDICAL ELECTRONICS, INC.
K791036 06/05/1979 FETASONDE UTERINE WORK MONITOR ROCHE MEDICAL ELECTRONICS, INC.
K791053 06/06/1979 THE DENVER SPLINT RONALD D. SHIPPERT, M.D.
K791199 06/28/1979 ANESTHESIA OXYGEN ANALYZER MODEL 101 RULE MEDICAL INSTRUMENTS, INC.
K791078 06/12/1979 ANTERIOR/POSTERIOR RESTORATIVE, BOND SCIENTIFIC PHARMACEUTICALS, INC.
K791132 06/18/1979 SCI-PHARM ORTHODONTIC ADHESIVE SCIENTIFIC PHARMACEUTICALS, INC.
K791067 06/12/1979 SCI-PHARM PAINT-ON RESTORATIVE SCIENTIFIC PHARMACEUTICALS, INC.
K791088 06/12/1979 MONOJECT PULP-CAPPING MATERIAL SHERWOOD MEDICAL CO.
K791060 06/08/1979 RAIN-X SHERWOOD MEDICAL CO.
K791089 06/12/1979 SHERWOOD NEBULIZER KIT SHERWOOD MEDICAL CO.
K791040 06/05/1979 SECTOR SCANNER, SDU-100, COMPUTERIZED SHIMADZU CORP.
K791080 06/12/1979 PLUS CHEM S.C.E. REAGENT SMITH KLINE DIAGNOSTICS, INC.
K791084 06/12/1979 PLUS CHEM, DETERMINATION OF ALT (GPT) SMITH KLINE DIAGNOSTICS, INC.
K791085 06/12/1979 PLUS CHEM, DETERMINATION OF LD (LDH-P) SMITH KLINE DIAGNOSTICS, INC.
K791082 06/12/1979 SPIN CHEM REAGENT, DETERMINATION OF AST SMITH KLINE DIAGNOSTICS, INC.
K791081 06/12/1979 SPIN CHEM REAGENT, DETERMINATION OF LDH- SMITH KLINE DIAGNOSTICS, INC.
K791083 06/12/1979 SPIN CHEM, DETERMINATION OF ALT (GPT) SMITH KLINE DIAGNOSTICS, INC.
K791162 06/25/1979 GELSKIN SPENCO MEDICAL CORP.
K791087 06/12/1979 PORTABLE PULSE GALVANIC STIMULATOR STAODYNAMICS, INC.
K791142 06/18/1979 HEARING AID, MODEL MA-1 STARKEY LABORATORIES, INC.
K791071 06/12/1979 MODEL MA3 BEHIND-THE-EAR MASKER/HEARING STARKEY LABORATORIES, INC.
K791203 06/28/1979 MODEL SE-1 EYEGLASS HEARING AID STARKEY LABORATORIES, INC.
K791048 06/06/1979 STIMTECH NEUROMUSCULAR STIMULATOR, C 600 STIMULATION TECHNOLOGY, INC.
K791146 06/18/1979 COLO-TAPE SUBURBAN OSTOMY SUPPLY CO., INC.
K791032 06/04/1979 CARDIAC CATHETERIZATION SHEETS/PACKS SURGIKOS, INC.
K791019 06/01/1979 MCSPADDEN CONDENSOR TECHDENT, INC.
K791173 06/25/1979 SURFLO INJECTION PLUG TERUMO AMERICA, INC.
K791110 06/14/1979 KINETIC DETERMINATION OF UV GLUCOSE THE DOW CHEMICAL CO.
K791074 06/12/1979 MODEL MHS-20, ATOMIC ABSORPTION ACCESS THE PERKIN-ELMER CORP.
K791017 06/01/1979 FLOW LIMITER TIMETER INSTRUMENT CORP.
K791106 06/13/1979 STERILE, DISPOSABLE CENTRIFUGE BOWL TRAVENOL LABORATORIES, S.A.
K791073 06/12/1979 WRENCH TRUTH, INC.
K791180 06/25/1979 CENTRIFICHEM SYSTEM 500 UNION CARBIDE CORP.
K791043 06/05/1979 LINDE OXYGEN CONCENTRATOR MODEL LOC-HC UNION CARBIDE CORP.
K791069 06/12/1979 LINDE OXYGEN THERAPY FLOWMETERS, L33-L34 UNION CARBIDE CORP.
K791177 06/25/1979 DISPIRO UTAH MEDICAL PRODUCTS, INC.
K791102 06/13/1979 CARY 210 SERIES, SPECTROPHOTOMETER VARIAN ASSOC., INC.
K791131 06/18/1979 FLU VEN TR-1 VENOSPITAL, INC.
K791130 06/18/1979 FLU-VEN TK-2 VENOSPITAL, INC.
K791050 06/06/1979 CENTRIA T3 UPTAKE TEST SET VENTREX LABORATORIES, INC.
K791187 06/26/1979 MODEL 810 VERI/TGS VERITE
K791034 06/05/1979 PIGGYBACK BREATHING CIRCUIT VITAL SIGNS, INC.
K791127 06/18/1979 POSIVAC VITAL SIGNS, INC.
K791026 06/04/1979 4F STERILE BALLOON-LESS, CATHETER 913-28 WATERS ASSOC., INC.
K791014 06/01/1979 DENTAL XERORADIOGRAPHY XEROX MEDICAL SYSTEMS
K791121 06/15/1979 ALLIGATOR FORECPTS, CUPPED FORCEPS XOMED, INC.
K791123 06/15/1979 EAR AND NOSE SPECULA XOMED, INC.
K791120 06/15/1979 MIDDLE EAR PICKS, HOOKS CURETTES, XOMED, INC.
K791059 06/08/1979 POPE OTO-WICK, STERILE & NON-STERILE XOMED, INC.
K791124 06/15/1979 SURGICAL SCISSORS XOMED, INC.
K791122 06/15/1979 TISSURE RETRACTORS XOMED, INC.


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