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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, non-selective and non-differential
510(k) Number K792276
Device Name BRAIN HEART INFUSION W/PABA, O.1%,
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 EYE ST. NW STE. 625
WASHINGTON,  DC  20006
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 EYE ST. NW STE. 625
WASHINGTON,  DC  20006
Regulation Number866.2300
Classification Product Code
JSG  
Date Received11/13/1979
Decision Date 12/19/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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