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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Gas Generating
510(k) Number K875362
Device Name BREWER GEL FOR ANAEROBES
Applicant
Fairleigh Dickinson Laboratories, Inc.
1249 Ambler Ave.
Abilene,  TX  79601
Applicant Contact JEANNETTE KING
Correspondent
Fairleigh Dickinson Laboratories, Inc.
1249 Ambler Ave.
Abilene,  TX  79601
Correspondent Contact JEANNETTE KING
Regulation Number866.2580
Classification Product Code
KZJ  
Date Received12/31/1987
Decision Date 01/27/1988
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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