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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name container, empty, for collection & processing of blood & blood components
510(k) Number BK960084
Tradename Gambro Hemofreeze Bag
Device Name Container, Empty, For the Collection '& Processing of Blood/Blood Components
Original Applicant
NPBI
runde zz 41, 7881 hm emmer compascuum
emmer-compascumm, 
Regulation Number864.9100
Classification Product Code
KSR  
Date Received11/01/1996
Decision Date 05/28/1998
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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