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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 K881502
Device Name BREWER GEL FOR CAMPYLOBACTER
Applicant
Fairleigh Dickinson Laboratories, Inc.
1249 Ambler Ave.
Abilene,  TX  79601
Applicant Contact MARK RANDEL
Correspondent
Fairleigh Dickinson Laboratories, Inc.
1249 Ambler Ave.
Abilene,  TX  79601
Correspondent Contact MARK RANDEL
Regulation Number866.2580
Classification Product Code
KZJ  
Date Received04/11/1988
Decision Date 04/27/1988
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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