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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 K950087
Device Name LOT 440
Applicant
MEDICAL INSTRUMENTS CORPORATION MIC AG
FRIEDHOFPLATZ 16, POB 706
CH-4502
SOLOTHURN,  CH CH-4502
Applicant Contact JOHN C MATHERLY
Correspondent
MEDICAL INSTRUMENTS CORPORATION MIC AG
FRIEDHOFPLATZ 16, POB 706
CH-4502
SOLOTHURN,  CH CH-4502
Correspondent Contact JOHN C MATHERLY
Regulation Number876.1400
Classification Product Code
FFT  
Date Received01/10/1995
Decision Date 02/06/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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