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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 K832533
Device Name SELENITE CYSTINE BROTH
Applicant
Otisville Biotech, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Otisville Biotech, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.2330
Classification Product Code
KZI  
Date Received07/29/1983
Decision Date 10/04/1983
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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