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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Transport, Aerobic
510(k) Number K760054
Device Name CULTURE TUBE, (VACUTAINER)
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 Number866.2900
Classification Product Code
JTW  
Date Received06/16/1976
Decision Date 08/03/1976
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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