FDA 510(k) Application Details - K991248

Device Classification Name Campylobacter Pylori

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510(K) Number K991248
Device Name Campylobacter Pylori
Applicant MEDICAL INSTRUMENTS CORPORATION MIC AG
FRIEDHOFPLATZ 16
SOLOTHURN 4502 CH
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Contact JOHN C MATHERLY
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Regulation Number 866.3110

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Classification Product Code LYR
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Date Received 04/12/1999
Decision Date 06/22/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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