FDA 510(k) Decisions During June, 1979  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K791057 06/20/1979 CAST BRACE COMPONENTS 3M COMPANY
K790905 06/15/1979 NUCLEAR SAMPLE READER ABBOTT LABORATORIES
K782113 06/01/1979 CAP, TAMPER PROOF PLASTIC ACACIA, INC.
K790901 06/27/1979 I.V. TUBING ORGANIZER ACUMED INSTRUMENTS CORP.
K790608 06/15/1979 BL BILIRUBINOMETER ADVANCED INSTRUMENTS, INC.
K790611 06/15/1979 OSMOMETER MODEL 3W11 ADVANCED INSTRUMENTS, INC.
K791042 06/13/1979 I.P.P.B. MANIFOLD & NEBULIZER, UNIVERSAL AIRLIFE, INC.
K790887 06/05/1979 TEE ADAPTER AIRLIFE, INC.
K790890 06/27/1979 TEMPO2-I DISPOSABLE THERMOMETERS AIRLIFE, INC.
K790891 06/27/1979 TEMPO2-II DISPOSABLE THERMOMETERS AIRLIFE, INC.
K790888 06/27/1979 TRACH "T" WITH ONE-WAY VALVES AIRLIFE, INC.
K791016 06/27/1979 ULTICARE 2500 TREATMENT CHAIR AMERICAN HEALTH CARE INDUSTRIES, INC.
K790753 06/28/1979 DIMENSIONALL ROTATOR AMERICAN HOSPITAL SUPPLY CORP.
K790840 06/28/1979 THYROID CONTROL SERA CODE QAS.101 AMERSHAM CORP.
K790999 06/22/1979 APOLLO HEART RATE INDICATOR APOLLO PRODUCTS, INC.
K790835 06/22/1979 DYNAJECT ATOMIC PRODUCTS CORP.
K790553 06/15/1979 CHOLESTEROL KIT, HDL-DS BECKMAN INSTRUMENTS, INC.
K791030 06/22/1979 HEMOGLOBIN AF/SC ELECTROPHORESIS CONTROL BECKMAN INSTRUMENTS, INC.
K790862 06/28/1979 BIOVATION DIGITAL URINOMETER BIOVATION, INC.
K790772 06/15/1979 CHEMTAB BOEHRINGER MANNHEIM CORP.
K790953 06/27/1979 "BORDISPO" BRAND HYPODERMIC NEEDLE BORDA PRODUCTS, INC.
K790754 06/01/1979 BROWNE MODEL CF-1 AND CF-1G BROWNE CORP.
K790478 06/01/1979 BROWNE MODEL UD-4DE BROWNE CORP.
K791020 06/27/1979 FLUID ADMINISTRATION SET FA-3160 BURRON MEDICAL PRODUCTS, INC.
K790854 06/05/1979 FORCEPS #101 AND #102 C. INTL.
K790982 06/27/1979 INSPIRON NEBULO TM 28 NEBULIZER KIT C.R. BARD, INC.
K791047 06/13/1979 NERVE STIMULATOR, DIGITAL PERIPHERAL C.R. BARD, INC.
K790773 06/15/1979 ENZYMATIC TRIGLYCERIDES-S.V.R. CALBIOCHEM-BEHRING CORP.
K790911 06/27/1979 RIA OF PROGESTERONE CALBIOCHEM-BEHRING CORP.
K790535 06/07/1979 CLAYTON COLON CLEANSING KIT CLAYTON MEDICAL PRODUCTS, INC.
K791001 06/22/1979 PENLIGHT/SWAB HOLDER CONCEPT, INC.
K772011 06/15/1979 WHOLEY OCCLUSION BALLOON CATHETER COOK, INC.
K790944 06/28/1979 CITRATE AGAR GEL AND BUFFER SET CORNING MEDICAL & SCIENTIFIC
K790943 06/22/1979 TRISEDTA-BORATE ELECTROPHORESIS FILM AGA CORNING MEDICAL & SCIENTIFIC
K790812 06/28/1979 COULTER ACCU-ZYME IIY-GT REAGENT KIT COULTER ELECTRONICS, INC.
K790824 06/27/1979 REPGREEN ULTRAFILTRATION MONITOR CYBEREX CORP.
K790756 06/11/1979 HEAT EXCHANGER COIL DELTA MEDICAL INDUSTRIES
K790996 06/27/1979 C.C.F. FEMORAL DEBRIDEMENT PROBE DEPUY, INC.
K791009 06/11/1979 SANTA CASA DISTRACTOR DEPUY, INC.
K791015 06/13/1979 "VOLUREX TM" DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP.
K790728 06/01/1979 "TOUCHLESS TM" FOLEY CATHETER KIT DIAMED DIVISION ILL. TOOL WORKS, INC.
K790565 06/11/1979 AORTIC ROOT CANNULA DLP, INC.
K790504 06/11/1979 "SANDEE" SANDING BLOCK DR. BERTRAM L. STEEL
K790958 06/28/1979 120 WELL HISTO-PLATE DYNATECH LABORATORIES, INC.
K790957 06/15/1979 HISTO-DISPENSER DYNATECH LABORATORIES, INC.
K790956 06/15/1979 HISTO-OILER DYNATECH LABORATORIES, INC.
K790974 06/20/1979 MIC-2000 INOCULATOR TEMPLATE DYNATECH LABORATORIES, INC.
K790971 06/20/1979 MIC-2000 QUAD INOCULUM TRAY DYNATECH LABORATORIES, INC.
K791049 06/28/1979 SYNALON ROLLER BOTTLE DYNATECH LABORATORIES, INC.
K791157 06/27/1979 360 HEMOCLIP APPLIERS EDWARD WECK, INC.
K790990 06/05/1979 REYNOLDS DOUBLE HEMOCLIP APPLIERS EDWARD WECK, INC.
K790444 06/11/1979 ELECATH MULTI-PURPOSE ARTERIAL SURGER ELECTRO-CATHETER CORP.
K791006 06/11/1979 SMART BILECTRODES ELECTRONICS FOR MEDICINE, INC.
K790670 06/27/1979 PULSE GENERATOR MODEL 629 ELEMA-SCHONANDER, INC.
K790545 06/06/1979 STRESS TESTING SYSTEM, LATERAL TILTING ENGINEERING DYNAMICS CORP.
K790544 06/05/1979 STRESS TESTING SYSTEM, MULTI-POSITION ENGINEERING DYNAMICS CORP.
K791092 06/12/1979 ESTERASE-CHLOROESTERASE, STAINING KIT EUREKA LABORATORIES, INC.
K791046 06/13/1979 ENDOTRACHEAL TUBES, LONG & SHORT TERM EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K790902 06/27/1979 INTEGRATED PATIENT STATIONS EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K791045 06/13/1979 MODEL GV-10 LANZ PRESSURE-VALVE EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K791044 06/13/1979 TRACHEOSTOMY TUBES, SHORT AND LONG TERM EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K790955 06/20/1979 COVER GARD FEM-GARD, INC.
K790954 06/20/1979 HEEL GARD FEM-GARD, INC.
K790995 06/11/1979 CONTEX FOAM TEK, INC.
K790973 06/15/1979 "LO-ION" GAMMA BIOLOGICALS, INC.
K790791 06/15/1979 ELECTROPHORESIS REAGENT SET, HDL GELMAN SCIENCES, INC.
K790942 06/27/1979 RADVIEW IMAGER SYSTEM GENERAL ELECTRIC CO.
K790786 06/15/1979 GLUCOSE (HK) REAGENT GILFORD DIAGNOSTICS
K790818 06/05/1979 MEDI-TRACE EEG CREME GRAPHIC CONTROLS CORP.
K790966 06/11/1979 ULTRASONIC HUMIDIFIER HANKSCRAFT DIV. OF GERBER PRODUCTS CO.
K790798 06/05/1979 FETAL MATURITY TEST PROCEDURE HELENA LABORATORIES
K791135 06/28/1979 LYOPHILIZED G-HB QUIK COLUMN CONTROL HELENA LABORATORIES
K790939 06/11/1979 MODEL 78501A PATIENT MONITORING SYSTEM HEWLETT-PACKARD CO.
K790655 06/15/1979 ABUSCREEN RIA FOR PHENCYCLIDINE HOFFMANN-LA ROCHE, INC.
K790793 06/22/1979 AMC "R" METACARPAL COMPONENT HOWMEDICA CORP.
K791113 06/28/1979 LOW IONIC STRENGTH SOLUTION (LISS) HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K790831 06/15/1979 ANTISTREPTOLYSIN (ASO) LATEX SLIDE TEST ICL SCIENTIFIC
K790548 06/01/1979 ENDOCARDIAL PACING LEAD, MODEL 476-01 INTERMEDICS, INC.
K790464 06/13/1979 FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO INTL. DIAGNOSTIC TECHNOLOGY
K790650 06/27/1979 WEISS EMERGENCY AIRWAY SYSTEM INTL. MEDICAL DEVICES LTD.
K790476 06/01/1979 QUICKSCAN HOLTER II INTL. MEDICAL, INC.
K790882 06/11/1979 LEAD INTRODUCER SET INTROSTAT
K790738 06/20/1979 HABITSABATER JACKSON ENT.
K790968 06/11/1979 CATHETER METAL HUB/NONRADIOPAQUE JELCO LABORATORIES
K790967 06/27/1979 CATHETER METAL HUB/RADIOPAQUE JELCO LABORATORIES
K790972 06/05/1979 KIMLON IMPERVIOUS STOCKINETTES KIMBERLY-CLARK CORP.
K791103 06/28/1979 LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT LEECO DIAGNOSTICS, INC.
K791112 06/15/1979 LIBCO 1,2,3, EYEGLASS FRAMES LIBCO EYEWEAR, INC.
K782154 06/21/1979 COLOSTOMY DEVICE, MACLET MAGNETIC MACLET MEDICAL DEVICES, INC.
K790947 06/28/1979 AUTO ENZYMATIC CHOLESTEROL MACOMB CHEMICAL CO.
K790559 06/01/1979 ALARM MADDAK, INC.
K791170 06/25/1979 MIS AURAL ACOUSTIC SCREENER MAICO HEARING INSTRUMENTS, INC.
K790411 06/01/1979 AUTO TRAUMA KIT MARSHALL ELECTRONICS, INC.
K791098 06/22/1979 SINGLE-USE MINI-BULLDOG MED GENERAL
K790952 06/05/1979 CLAMP COVERS MEDI-SPEC
K790803 06/28/1979 SYRINGE TONOMETER MEDICOR USA LTD.
K791070 06/20/1979 ACCU-SORB STERILE STOCKINETTES MEDLINE INDUSTRIES, INC.
K790988 06/11/1979 MODEL 6971 W/ DBS WIRE MEDTRONIC VASCULAR
K791093 06/20/1979 MODELS 2411/2418 VENTRICULAR-INHIBITED MEDTRONIC VASCULAR
K790930 06/22/1979 TRACHE FITTING M-307 MEM MEDICAL, INC.
K790992 06/22/1979 PSEUDO-PALETTE TM MICRO-PALETTES, INC.
K790991 06/22/1979 YEAST-PALETTE TM MICRO-PALETTES, INC.
K790906 06/27/1979 AUTOPAK CORTISOL TEST DELIVERY SYSTEM MICROMEDIC SYSTEMS
K790907 06/27/1979 AUTOPAK TEST DELIVERY SYSTEM MICROMEDIC SYSTEMS
K790584 06/15/1979 AMES TDA/GENTGMICIN MILES LABORATORIES, INC.
K790965 06/28/1979 REAGENT STRIPS FOR URINALYSIS MILES LABORATORIES, INC.
K790445 06/28/1979 ULTRA-FREE MILLIPORE CORP.
K791107 06/22/1979 STOPCOCK, THREE WAY NORTON PERFORMANCE PLASTICS CORP.
K790653 06/15/1979 NOVA 3 CHLORIDE/TOTAL DIOXIDE ANALYZER NOVA CORP.
K790961 06/28/1979 LIQUID SCINTILLATION COUNTER NUCLEAR ENT. LTD.
K790734 06/15/1979 PREGNOSTICON PREGNANCY TEST KIT ORGANON, INC.
K790813 06/28/1979 MULTECON BLOOD GAS CONTROL ORTHO DIAGNOSTICS, INC.
K782018 06/04/1979 LEADS, IMPLANTABLE CARDIAC PACEMAKERS OSCOR INC.
K791023 06/28/1979 PROTHROMBIN FREE BEEF PLASMA (PFB) PACIFIC HEMOSTASIS
K790879 06/01/1979 ULTIPOR SOLUTION CONTAINER FILTER PALL BIOMEDICAL PRODUCTS CO.
K790896 06/05/1979 TWO-WAY ANESTHESIA FILTER PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K791002 06/01/1979 ECG ELECTRODES, PEDIATRIC-FOAM TAPE PHYSIO-CONTROL CORP.
K791003 06/01/1979 ECG ELECTRODES, PEDIATRIC-MICROPOROUS TA PHYSIO-CONTROL CORP.
K790757 06/01/1979 LIFEPAK 5 MONITOR, CASSETTE, #800923-01 PHYSIO-CONTROL CORP.
K791062 06/20/1979 BOUNDARY SPECIALTY GOWN PROCTER & GAMBLE MFG. CO.
K790696 06/20/1979 RDI-1 HOLLOW FIBER DIALYZER RENAL DEVICES, INC.
K791125 06/27/1979 PLUG-LOK CEMENT RESTIRCTOR RICHARD'S MEDICAL EQUIP., INC.
K790761 06/01/1979 FETASONDE MODEL 2108 ROCHE MEDICAL ELECTRONICS, INC.
K790969 06/27/1979 ARGYLE URINE METER SHERWOOD MEDICAL CO.
K790865 06/28/1979 LANCER HDL SEPARATION KIT SHERWOOD MEDICAL CO.
K791060 06/15/1979 RAIN-X SHERWOOD MEDICAL CO.
K790838 06/11/1979 ARTERIAL EMBOLECTOMY CATHETER (MODIFIED) SHILEY, INC.
K790938 06/13/1979 SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO SHILEY, INC.
K790923 06/22/1979 MI-MARK ENDOCERVICAL SAMPLING SET SIMPSON/BASYE, INC.
K790916 06/22/1979 CK-NUC REAGENT SMITH KLINE DIAGNOSTICS, INC.
K790918 06/22/1979 ESKLAB REAGENT TABLETS SMITH KLINE DIAGNOSTICS, INC.
K790917 06/22/1979 SPIN CHEM CK-NAC REAGENT SMITH KLINE DIAGNOSTICS, INC.
K790841 06/27/1979 TG 2, TRI-GARD PRESSURE MONITOR SORENSEN RESEARCH
K790814 06/27/1979 DELTA PUMP SPIESS DESIGN, INC.
K790897 06/15/1979 QUAD IV CUSTOM IMPRESSION TRAY STED, INC.
K791032 06/15/1979 CARDIAC CATHETERIZATION SHEETS/PACKS SURGIKOS, INC.
K790937 06/15/1979 EMIT AUTO DIGOXIN ASSAY SYVA CO.
K790398 06/15/1979 EMIT-D.A.U. PHENCYCLIDINE URINE LOW SYVA CO.
K790401 06/15/1979 PHENCYCLIDINE URINE ASSAY SYVA CO.
K790399 06/15/1979 URINE MEDIUM CALIBRATOR SYVA CO.
K790400 06/15/1979 URINE NEGATIVE CALIBRATOR SYVA CO.
K790919 06/28/1979 HPL RIA KIT TECHNIA DIAGNOSTICS LTD.
K790805 06/06/1979 DRUG ABUSE DIPSTICKS TECHNICAL RESOURCES, INC.
K790699 06/01/1979 TECNOL BODY HOLDER TECNOL NEW JERSEY WOUND CARE, INC.
K790834 06/28/1979 UV URIC ACID DETERMINATION THE DOW CHEMICAL CO.
K791021 06/15/1979 MUSCLE TESTING GUN THE ORTHODYN CO.
K791073 06/20/1979 WRENCH TRUTH, INC.
K791043 06/13/1979 LINDE OXYGEN CONCENTRATOR MODEL LOC-HC UNION CARBIDE CORP.
K791069 06/27/1979 LINDE OXYGEN THERAPY FLOWMETERS, L33-L34 UNION CARBIDE CORP.
K791050 06/15/1979 CENTRIA T3 UPTAKE TEST SET VENTREX LABORATORIES, INC.
K790800 06/15/1979 CENTRIA T4 RIA TEST SET VENTREX LABORATORIES, INC.
K790908 06/27/1979 RIA, TEST SET CENTRIA T3 VENTREX LABORATORIES, INC.
K790945 06/01/1979 MODEL 113 TREONIC IP3 DIGITAL SYRINGE PU VICKERS AMERICA MEDICAL CORP.
K791034 06/15/1979 PIGGYBACK BREATHING CIRCUIT VITAL SIGNS, INC.
K790666 06/01/1979 VITALITH S 3000 SERIES VITATRON MEDICAL BV
K790874 06/05/1979 "AMALCAP-NON-GAMMA-2" VIVADENT (USA), INC.
K790595 06/15/1979 DENTAL ALGINATE IMPRESSION MATERIAL WALLACE A. ERICKSON & CO.
K790593 06/15/1979 DENTAL CEMENT, ZINC PHOSPHATE WALLACE A. ERICKSON & CO.
K790594 06/15/1979 DENTAL COMPOSITE RESTORATIVE MATERIAL WALLACE A. ERICKSON & CO.
K790596 06/15/1979 ENAMEL BOND SYSTEM WALLACE A. ERICKSON & CO.
K790592 06/15/1979 IMPRESSION MATERIAL, RUBBER WALLACE A. ERICKSON & CO.
K790986 06/28/1979 RF CONTROLS WAMPOLE LABORATORIES
K791026 06/22/1979 4F STERILE BALLOON-LESS, CATHETER 913-28 WATERS ASSOC., INC.
K790946 06/05/1979 GORDON "IVS" INTRAVENOUS STABILIZER WHITMAN MEDICAL CORP.
K790866 06/15/1979 "14 KARAT CASTING GOLD" WILLIAMS GOLD REFINING CO., INC.
K791121 06/27/1979 ALLIGATOR FORECPTS, CUPPED FORCEPS XOMED, INC.
K790915 06/27/1979 JUHN TYM-TAP XOMED, INC.
K791124 06/27/1979 SURGICAL SCISSORS XOMED, INC.
K790722 06/15/1979 PROPHYLAXIS ANGLE YOUNG DENTAL MANUFACTURING CO 1, LLC.
K790723 06/15/1979 PROPHYLAXIS CUPS AND POLISHERS YOUNG DENTAL MANUFACTURING CO 1, LLC.
K790987 06/22/1979 ZIMMER R TOTAL SHOULDER II ZIMMER, INC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact