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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 BK980014
Tradenames HemaSure r|LS Pre-Storage Leukoreduction Filtration System for Red Blood Cells, HemaSure r|LS Pre-Storage Leukoreduction Filtration System with spike for Red Blood Cells
Device Name Microfilter, Blood Transfusion
Original Applicant
Hemasure, Inc.
140 locke drive
marlborough,  MA  01752
Regulation Number880.5440
Classification Product Code
CAK  
Date Received05/18/1998
Decision Date 05/27/1999
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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