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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 BK950008
Tradename LeukoNet Pre Storage Leukodepletion Filteration System
Device Name Set, Transfer (Blood/Plasma)
Original Applicant
Hemasure, Inc.
140 locke drive
marlborough,  MA  01752
Regulation Number864.9875
Classification Product Code
KSB  
Date Received12/29/1994
Decision Date 06/28/1995
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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