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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name container, empty, for collection & processing of blood & blood components
510(k) Number BK920027
Tradename Plasma Pooling Bag
Device Name Container, Empty, For the Collection '& Processing of Blood/Blood Components
Original Applicant
Haemonetics Manufacturing Inc.
400 wood road
braintree,  MA  02184
Regulation Number864.9100
Classification Product Code
KSR  
Date Received09/21/1992
Decision Date 04/13/1993
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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