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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name microfilter, blood transfusion
510(k) Number BK080060
Tradename Leucolab LCG2 Leukoreduction System for AS-1, AS-3, and AS-5 Red Blood Cells
Device Name Microfilter, Blood Transfusion
Original Applicant
MacoProductions S.A.S.
3075 breckinridge blvd.
suite 405
duluth,  GA  30096
Regulation Number880.5440
Classification Product Code
CAK  
Date Received10/31/2008
Decision Date 01/14/2009
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
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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