FDA 510(k) Application Details - K964014

Device Classification Name Campylobacter Pylori

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510(K) Number K964014
Device Name Campylobacter Pylori
Applicant KENLOR INDUSTRIES, INC.
1560 EAST EDINGER AVE.,
SUITE A-1
SANTA ANA, CA 92705 US
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Contact KAMALES SOM
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Regulation Number 866.3110

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Classification Product Code LYR
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Date Received 10/07/1996
Decision Date 03/03/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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