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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 BK050020
Tradename LeukoConnect - Pre-Storage Sterile Connect Leukoreduction Set with Sepacell Filter for Red Blood Cells in additive solution
Device Name Microfilter, Blood Transfusion
Original Applicant
Fenwal Inc
three corporate drive
lake zurich,  IL  60047
Regulation Number880.5440
Classification Product Code
CAK  
Date Received04/05/2005
Decision Date 05/17/2005
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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