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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, Selective And Non-Differential
510(k) Number K834422
Device Name PHENYLETHYL ALCOHOL AGAR PLATE
Applicant
Otisville Biotech, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Otisville Biotech, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.2360
Classification Product Code
JSJ  
Date Received12/15/1983
Decision Date 10/23/1984
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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