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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 BK020033
Tradename Imugard III-PL Leukocyte reduction filter
Device Name Microfilter, Blood Transfusion
Original Applicant
Terumo Medical Corporation
125 blue ball road
elkton,  MD  21921
Regulation Number880.5440
Classification Product Code
CAK  
Date Received08/21/2002
Decision Date 05/22/2003
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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