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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 BK210658
Tradename IMUGARD® WB PLT Platelet Pooling Set
Device Name Container, Empty, For the Collection '& Processing of Blood/Blood Components
Original Applicant
Terumo BCT, Inc
10811 w. collins ave.
lakewood,  CO  80215
Regulation Number864.9100
Classification Product Code
KSR  
Date Received12/02/2021
Decision Date 08/26/2022
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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