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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 BK070024
Tradename LEUKOSEP® HRC-600-C Leukocyte Reduction Filtration System for Red Blood Cells
Device Name Microfilter, Blood Transfusion
Original Applicant
Hemerus Medical, LLC
5000 township parkway
saint paul,  MN  55110
Regulation Number880.5440
Classification Product Code
CAK  
Date Received05/03/2007
Decision Date 08/23/2007
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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