FDA 510(k) Applications Received During July, 1977

FDA 510(k) Number Submission Date Device Name Applicant Contact
K771253 07/11/1977 HEMOX-ANALYZER 3M COMPANY
K771320 07/18/1977 CRYOSURGICAL EQUIPMENT A.S.M.O.T.
K771345 07/20/1977 BICHROMATIC ANALYZER ABA-200 ABBOTT LABORATORIES
K771365 07/25/1977 CREATININE ANALYSIS PRODUCTS ABBOTT LABORATORIES
K771235 07/11/1977 HTSH RIA HUMAN THYROID HORMONE RIA ABBOTT LABORATORIES
K771321 07/18/1977 HYDRON BURN BANDAGE ABBOTT LABORATORIES
K771228 07/07/1977 LIFECARE EMPTY CONTAINER ABBOTT LABORATORIES
K771309 07/18/1977 RIA FOR TOTAL THYROXINE ABBOTT LABORATORIES
K771236 07/11/1977 TRIOBEAD-125 DIAGNOSTIC KIT ABBOTT LABORATORIES
K771301 07/15/1977 DIGITAL RADIATION DETECTOR ACTUS, INC.
K771350 07/21/1977 AMBU RESUSCITATOR AIR-SHIELDS, INC.
K771339 07/19/1977 MALE LUER LOCK PLUG AMERICAN VIGGO
K771266 07/13/1977 STEAM STERILIZER AMSCO HOSPITAL PRODUCTS CO.
K771264 07/11/1977 FLOTATION THERAPY BED AQUARIUS MEDICAL SERVICES
K771262 07/11/1977 PACEMAKER & CARDIAC LEAD, BIPOLAR ARCO MEDICAL PRODUCTS CO.
K771260 07/13/1977 LINEAR ACCELERATOR G-2900 ATOMIC ENERGY OF CANADA
K771406 07/29/1977 GUTTA GUN AUS-TEX DENTAL MFG. & DESIGN
K771385 07/27/1977 2 JET SET BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K771370 07/25/1977 ICROTAINEO BRAND TUBE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K771335 07/18/1977 CREATININE ANALYZER 2 BECKMAN INSTRUMENTS, INC.
K771369 07/25/1977 LIQ. SCINTILLATION SPECTROPHOTOMETEO BECKMAN INSTRUMENTS, INC.
K771241 07/11/1977 SPIR-E-VAC BREATHING SERVICES, INC.
K771254 07/12/1977 ACCU. CROWN COLD CURE BRIAR CLIFF, INC.
K771261 07/11/1977 ADVANSET C.R. BARD, INC.
K771394 07/28/1977 ELECTRONIC STETHESCOPE C.R. BARD, INC.
K771352 07/21/1977 ELECTROSURG. PATIENT GROUNDING PLATE C.R. BARD, INC.
K771393 07/28/1977 ELHCTRONIC SPHYGMOMANOMETER C.R. BARD, INC.
K771229 07/07/1977 STERILIZERS, 3100 SERIES TRIM LINE CASTLE CO.
K771368 07/25/1977 PORTABLE INFANT VENTILATOR CAVITRON CORP.
K771371 07/25/1977 SCREENING COMPUTEO SC-20 CAVITRON CORP.
K771201 07/05/1977 FORMALIN BUFFER CONCENTRATE CENTRAL LABS. ASSOC. MD PATHOLOGISTS
K771893 07/08/1977 DISPOSABLE ELHCTRODE CHASE MEDICAL SERVICES
K771198 07/01/1977 LUMI-AGGREGOMETER CHRONO-LOG CORP.
K771324 07/18/1977 3-(N-MORPHOLINS)-PROPANE SULFONIC ACID CORNING MEDICAL & SCIENTIFIC
K771323 07/18/1977 ELECTROPHORESIS OVEN THERMOMETER CORNING MEDICAL & SCIENTIFIC
K771322 07/18/1977 ELECTROPHORESIS POWER SUPPLY TESTER CORNING MEDICAL & SCIENTIFIC
K771303 07/15/1977 FLAME PHOTOMETER MODEL 460 CORNING MEDICAL & SCIENTIFIC
K771346 07/20/1977 CI-TROL COAGULATION CONTROLS II & III DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K771214 07/05/1977 SUPERFINE DIAMONDS DEN-MAT CORP.
K771218 07/05/1977 INTRA-ARTICULAR SHAVER DYONICS, INC.
K771233 07/07/1977 PHENYTOIN ANALYTICAL TEST PACKS E.I. DUPONT DE NEMOURS & CO., INC.
K771223 07/05/1977 GRAY TONE IMAGING FILM EASTMAN KODAK COMPANY
K771245 07/11/1977 MODEL 2/2 ANALYZER EASTMAN KODAK COMPANY
K771190 07/01/1977 ABRAMSON TRACHEA HOOK & RETRACTOR EDWARD WECK, INC.
K771331 07/18/1977 CONDUCTIVE ELECTRODE GEL EDWARD WECK, INC.
K771187 07/01/1977 DERMAHOOK #382-805 EDWARD WECK, INC.
K771329 07/18/1977 DISP. GROUND PAD PREGELLED EDWARD WECK, INC.
K771330 07/18/1977 DISP. GROUND PLATE EDWARD WECK, INC.
K771191 07/01/1977 HEISS RETRACTOR EDWARD WECK, INC.
K771189 07/01/1977 HOT TEMP CAUTERY EDWARD WECK, INC.
K771192 07/01/1977 LOWMAN BONE FORCEP EDWARD WECK, INC.
K771186 07/01/1977 MICRO BI-POLAR FORCEPS #39-200 EDWARD WECK, INC.
K771332 07/18/1977 PATIENT GROUNDING CABLES EDWARD WECK, INC.
K771376 07/25/1977 IFA ANTI-NDNA ELECTRO-NUCLEONICS LABORATORIES, INC.
K771349 07/21/1977 MODIFICATION TO KIDNEY DIALYZER ERIKA, INC.
K771326 07/18/1977 NIMETIC BONDING MATERIAL ESPE GMBH (US)
K771325 07/18/1977 NIMETIC ETCHING GEL ESPE GMBH (US)
K771328 07/18/1977 UVIOBOND ESPE GMBH (US)
K771327 07/18/1977 UVIOFIL ESPE GMBH (US)
K771299 07/14/1977 EMERGENCY OXYGEN RESUSCITATOR FRASER SWEATMAN, INC.
K771239 07/11/1977 GOAT LAMBDA-LIGHT CHAIN ANTIHUMAN SERUM G.D. SEARLE AND CO.
K771238 07/11/1977 RID PLATES & INTENSI. FOR HUMAN IGE ETC G.D. SEARLE AND CO.
K771234 07/11/1977 TSH RIA REAGENT SET G.D. SEARLE AND CO.
K771227 07/07/1977 AK-10 GAMBRO, INC.
K771388 07/27/1977 AMYLASE ULTRAZYME PLUS HARLECO
K771389 07/27/1977 CK-1 ULTRAZYME PLUS HARLECO
K771390 07/27/1977 HISTOCHEMICAL AFB DEMONSTRATION HARLECO
K771357 07/22/1977 GROUP AUDITORY TRAINER HC 431R HC ELECTRONICS
K771356 07/22/1977 POST-AURICULAR HEARING AID HC 880 HC ELECTRONICS
K771360 07/25/1977 ECG SCOPE MODEL 7833 HEWLETT-PACKARD CO.
K771380 07/26/1977 ELAPSED TIME INDICATOR MODEL 21361A HEWLETT-PACKARD CO.
K771194 07/01/1977 FETAL/MATERNAL ALRM MODULE - 21595A HEWLETT-PACKARD CO.
K771195 07/01/1977 FETAL/MATERNAL REPEATER - 21596A HEWLETT-PACKARD CO.
K771196 07/01/1977 MARKER GENERATOR MODULES - 21597A HEWLETT-PACKARD CO.
K771361 07/25/1977 PHYSIOLOGICAL PRESSURE TRANSDUCER 1290A HEWLETT-PACKARD CO.
K771224 07/05/1977 RADOVAN SUBCUTANEOUS TISSUE EXPANDER HEYER SCHULTE CORP.
K771354 07/22/1977 PARALLEL PLATE DIALYZERS HOSPAL MEDICAL CORP.
K771408 07/29/1977 WROUGHT (FORGED) VITALLIUM HOWMEDICA CORP.
K771259 07/11/1977 ALBUMIN TEST, HMA ALBUMIN TEST HYCEL, INC.
K771343 07/20/1977 LDH-INT TEST HYCEL, INC.
K771353 07/22/1977 PLATELET COUNTER & HEMATOCRIT ACCES. HYCEL, INC.
K771226 07/01/1977 LAS-R TEST PROGRAM HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K771337 07/19/1977 I.L. MODEL 643 FLAME PHOTOMETER INSTRUMENTATION LABORATORY CO.
K771374 07/25/1977 SCANNER TREND SYSTEM INSTRUMENTS FOR CARDIAC RESEARCH
K771257 07/11/1977 ACRY TEMP INTERSTATE DENTAL CO., INC.
K771248 07/11/1977 SILICONE IMPRESSION MATEOIAL INTERSTATE DENTAL CO., INC.
K771258 07/12/1977 BLOOD CELL SEPARATOR 2997 INTL. BUSINESS MACHINES
K771372 07/25/1977 SYSTEM II IREX CORP.
K771344 07/13/1977 GUSBERG HYSTERECTOMY CLAMP J. SKLAR MFG. CO., INC.
K771381 07/26/1977 IV CATHETER HUB JELCO LABORATORIES
K771383 07/27/1977 ALLOY DISPOS-A-CAP DENTAL SCHOOL CAP JOHNSON & JOHNSON PROFESSIONALS, INC.
K771396 07/28/1977 DISPENSER, MERCURY & TABLET/POWDER JOHNSON & JOHNSON PROFESSIONALS, INC.
K771242 07/11/1977 ANTISERA TO HUMAN FAB FRAGMENT KENT LABORATORIES, INC.
K771243 07/11/1977 ANTISERA TO HUMAN FAB FRAGMENT KENT LABORATORIES, INC.
K771403 07/29/1977 EASE (MODIFICATION TO) L.D. CAULK CO.
K771400 07/29/1977 IMPREGNATED DENTAL FLOSS L.D. CAULK CO.
K771399 07/29/1977 LIP & CHEEK RETRACTOR L.D. CAULK CO.
K771402 07/29/1977 NUVA-COTE (MODIFICATION TO) L.D. CAULK CO.
K771404 07/29/1977 NUVA-FIL COMPOSITE RESTORATIVE (MODI.) L.D. CAULK CO.
K771401 07/29/1977 PROPHY PASTE L.D. CAULK CO.
K771398 07/29/1977 SHELL VENEER L.D. CAULK CO.
K771252 07/11/1977 CB600, TURBINE CONTROL BOL LITTON DENTAL PRODUCTS
K771251 07/11/1977 HU:500, HYGIENASSIST LITTON DENTAL PRODUCTS
K771249 07/07/1977 JOY LIGHT M.D. INTL., INC.
K771312 07/18/1977 BLOOD UREA NITROGEN (BUN) REAGENT MALLINCKRODT CRITICAL CARE
K771219 07/05/1977 BRONCHO-CATH MALLINCKRODT CRITICAL CARE
K771310 07/18/1977 CALCIUM REAGENT MALLINCKRODT CRITICAL CARE
K771313 07/18/1977 CHOLESTEROL REAGENT MALLINCKRODT CRITICAL CARE
K771311 07/18/1977 GLUCOSE REAGENT (HEXOHINASE) MALLINCKRODT CRITICAL CARE
K771314 07/18/1977 GLUCOSE REAGENT (O-TOLUIDINE) MALLINCKRODT CRITICAL CARE
K771366 07/25/1977 INTERPLANTS MAURICES J. FAGAN, JR. B.S., D.D.S.
K771377 07/25/1977 THYRODOT-4, THYRODOT-SH MEDCOM DIAGNOSTICS, INC.
K771231 07/07/1977 ARTEOIAL LINE KIT MEDICAL DISPOSABLES INTL., INC.
K771230 07/07/1977 PERCUTANEOUS INTRODUCER SHEATH SET MEDICAL DISPOSABLES INTL., INC.
K771395 07/28/1977 LAPAROTOMY SPONGES, STERILE MEDLINE INDUSTRIES, INC.
K771382 07/26/1977 IMMUNOSTAT T3 UPTAKE TEST MELOY LABORATORIES, INC.
K771308 07/18/1977 TISSUE-TEK III V.I.P. MILES LABORATORIES, INC.
K771220 07/05/1977 T3 RIA TEST SYSTEM MONOBIND
K771221 07/05/1977 T4 RIA TEST SYSTEM MONOBIND
K771222 07/05/1977 TSH RIA TEST SYSTEM MONOBIND
K771387 07/27/1977 MONITORING LINES & FLUID ADMIN. NORTON PERFORMANCE PLASTICS CORP.
K771341 07/19/1977 SPINSEP-TBG NUCLEAR DIAGNOSTICS, INC.
K771378 07/20/1977 NEO TSH-RIA KIT NUCLEAR MEDICAL SYSTEMS, INC.
K771304 07/14/1977 LIQUAEMIB SODIUM PRESERVATIVE, ETC. ORGANON, INC.
K771305 07/14/1977 LIQUAEMIN SODIUM, HEPARIN SODIUM ETC. ORGANON, INC.
K771397 07/29/1977 MONOSTICON TEST ORGANON, INC.
K771359 07/25/1977 ALLERGIST PACK SYRINGES PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K771265 07/13/1977 PRESSURE MONITOR MANOMETRIC SYS. PHYSIO-CONTROL CORP.
K771347 07/20/1977 R&R ALSTON CARBIDE BURS RANSOM AND RANDOLPH
K771407 07/29/1977 LUNG VOLUME & PRESSURE MONITOR RESEARCH DEVELOPMENT CORP.
K771307 07/18/1977 BAIN BREATHING CIRCUIT RESPIRATORY CARE, INC.
K771367 07/25/1977 CHOLEDOCHOSCOPE SYSTEM RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K771217 07/05/1977 ANESTHESIA RESPIRATOR RULE MEDICAL INSTRUMENTS, INC.
K771237 07/11/1977 NERVE STIMULATORS RULE MEDICAL INSTRUMENTS, INC.
K771225 07/05/1977 AP ISOTROL, #A 0140 SIGMA CHEMICAL CO.
K771244 07/11/1977 2,2DIMETHOXY-2-PHENYLACETOPHENONE SOLAR LABORATORIES, INC.
K771379 07/26/1977 FETAL MONITORING SYS. MODEL FM3R SONICAID, INC.
K771246 07/11/1977 ALARM SYS FOR NITROUS OXIDE SYS. STAR DENTAL MFG. CO.
K771247 07/11/1977 CORE MATERIAL STAR DENTAL MFG. CO.
K771300 07/13/1977 INTRAVENOUS INFUSION PUMP STEWART-NAUMANN LABORATORIES
K771200 07/05/1977 ORTHOSCOPE STRYKER CORP.
K771199 07/05/1977 SURGIPULSE HEART RATE MONITOR STRYKER CORP.
K771188 07/01/1977 REVERSING CLICK GENERATOR RCG6 TECA, INC.
K771384 07/27/1977 AUTOZYME IMMOBILIZED ENZYME COIL TECHNICON INSTRUMENTS CORP.
K771336 07/18/1977 SMA II TECHNICON INSTRUMENTS CORP.
K771206 07/05/1977 AV FISTULA NEEDLE SET TERUMO AMERICA, INC.
K771203 07/05/1977 DISP. HYPODERMIC NEEDLE TERUMO AMERICA, INC.
K771211 07/05/1977 DOPPLER (UTD-5 & UTD-6) TERUMO AMERICA, INC.
K771205 07/05/1977 HYPODERMIC SYRINGE TERUMO AMERICA, INC.
K771212 07/05/1977 SAFEED DISP. PLASTIC CATHETER TERUMO AMERICA, INC.
K771204 07/05/1977 SURFLO WINGED INFUSION SET TERUMO AMERICA, INC.
K771209 07/05/1977 TERUFUSION BLOOD ADMIN. SET TERUMO AMERICA, INC.
K771207 07/05/1977 TERUFUSION DONOR SET TERUMO AMERICA, INC.
K771210 07/05/1977 UROGARD URINARY DRAINAGE BAG TERUMO AMERICA, INC.
K771263 07/11/1977 RADIOMHTER OSM-2 HEMOXIMETER THE LONDON CO.
K771348 07/21/1977 ECONOWRAP PAPER C.S.R. WRAP TOWER PRODUCTS, INC.
K771364 07/25/1977 LUBE JEL TRAVENOL LABORATORIES, S.A.
K771375 07/25/1977 PRESSURE MODULE 5M1247 TRAVENOL LABORATORIES, S.A.
K771255 07/12/1977 CEBTRIA DIGOXIN RIA UNION CARBIDE CORP.
K771216 07/05/1977 CENTRIFICHEM TRIGLYCEOIDE CALI, STD. SET UNION CARBIDE CORP.
K771215 07/05/1977 CENTRIFICHEM TRIGLYCERIDE CALI. STD. UNION CARBIDE CORP.
K771197 07/01/1977 NORTON ENDOTRACHEAL V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K771302 07/15/1977 PFISTER-SCHWARTZ STONE RETRIEVER V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K771358 07/22/1977 CLINAC 20 VARIAN ASSOC., INC.
K771256 07/08/1977 GAS CHROMATOGRAPH VARIAN ASSOC., INC.
K771362 07/18/1977 FLU VEN 0150 VENOSPITAL, INC.
K771306 07/14/1977 THERMOCATH VICTORY ENGINEERING CORP.
K771202 07/05/1977 WALPEO TABLH WALPEO CORP.
K771392 07/28/1977 ACCU-TRODE (DISP. ECG ELECTRODE) WARNER/CHILCOTT


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