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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name filter, blood, dialysis
510(k) Number K841307
Device Name BBL GASPAK POUCH
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 Number876.5820
Classification Product Code
FKJ  
Date Received03/30/1984
Decision Date 05/14/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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