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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 BK910019
Tradename Pall BPF4B Leukocyte Removal Blood Processing Filter wiht Attached Tubing and Blood Bag
Device Name Microfilter, Blood Transfusion
Original Applicant
Medsep Corporation
2200 northern boulevard
east hills,  NY  11548 1289
Regulation Number880.5440
Classification Product Code
CAK  
Date Received08/08/1991
Decision Date 01/16/1992
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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