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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 BK990044
Tradenames Haemonetics LN832F, Two Unit Red Cells Disposable Set with Leukocyte reduction Filter
Device Name Container, Empty, For the Collection '& Processing of Blood/Blood Components
Original Applicant
Haemonetics Corporation
400 wood road
braintree,  MA  02184 9114
Regulation Number864.9100
Classification Product Code
KSR  
Date Received12/08/1999
Decision Date 10/27/2000
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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