FDA 510(k) Application Details - K950087

Device Classification Name Electrode, Ph, Stomach

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510(K) Number K950087
Device Name Electrode, Ph, Stomach
Applicant MEDICAL INSTRUMENTS CORPORATION MIC AG
FRIEDHOFPLATZ 16, POB 706
CH-4502
SOLOTHURN CH-4502 CH
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Contact JOHN C MATHERLY
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Regulation Number 876.1400

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Classification Product Code FFT
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Date Received 01/10/1995
Decision Date 02/06/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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