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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K842400
Device Name BIOTIS N.Y.C. CARBOHYDRATE FERMENTA-
Applicant
Otisville Biotech, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Otisville Biotech, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Date Received06/19/1984
Decision Date 07/02/1984
Decision Substantially Equivalent (SESE)
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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