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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 K871922
Device Name PORTABLE PH, MV, TEMP METER W/AUTO. TEMP COMPENSA.
Applicant
Chemfet Corp.
777-108th Ave. NE (1200)
Rainier Bank Plz.
Bellevue,  WA  98004
Applicant Contact LORI CADWELL
Correspondent
Chemfet Corp.
777-108th Ave. NE (1200)
Rainier Bank Plz.
Bellevue,  WA  98004
Correspondent Contact LORI CADWELL
Regulation Number876.1400
Classification Product Code
FFT  
Date Received05/18/1987
Decision Date 10/20/1987
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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