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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ph, Stomach
510(k) Number K903646
Device Name GASTROGRAPH
Applicant
Medics Instrument Corp.
Ch-4502 Solothurn
Pob 706, Hauptgasse 25
Friedhofplatz 16 , West,  DE
Applicant Contact JOHN C MATHERLY
Correspondent
Medics Instrument Corp.
Ch-4502 Solothurn
Pob 706, Hauptgasse 25
Friedhofplatz 16 , West,  DE
Correspondent Contact JOHN C MATHERLY
Regulation Number876.1400
Classification Product Code
FFT  
Date Received08/14/1990
Decision Date 11/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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