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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, transfer (blood/plasma)
510(k) Number BK920032
Tradename Sepacell Pre-storage Leukocyte Depletion Set for Red Cell
Device Name Set, Transfer (Blood/Plasma)
Original Applicant
Fenwal Inc
three corporate drive
lake zurich,  IL  60047
Regulation Number864.9875
Classification Product Code
KSB  
Date Received11/04/1992
Decision Date 06/07/1993
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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