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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Enriched
510(k) Number K860410
Device Name BIOTIS COOKED MEAT
Applicant
Otisville Biotech, Inc.
P.O. Box 567
Otisville,  NY  10963
Applicant Contact ERNEST M GREEN
Correspondent
Otisville Biotech, Inc.
P.O. Box 567
Otisville,  NY  10963
Correspondent Contact ERNEST M GREEN
Regulation Number866.2330
Classification Product Code
KZI  
Date Received02/03/1986
Decision Date 02/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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