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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name container, empty, for collection & processing of blood & blood components
510(k) Number BK180188
Tradename Leukocyte Reduction Filter for Red Blood Cells
Device Name Container, Empty, For the Collection '& Processing of Blood/Blood Components
Original Applicant
PuriBlood Medical Co. Ltd.
2f., no.11, gongye e. 9th rd.
paoshan hsiang
Hsinchu Hsien,  30075,  TAIWAN
Regulation Number864.9100
Classification Product Code
KSR  
Date Received02/28/2018
Decision Date 11/23/2018
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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