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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 BK160108
Tradename TSCD-II Sterile Tubing Welder with or without Trucise Total System (TM), Model ME-SC203A
Device Name Set, Transfer (Blood/Plasma)
Original Applicant
Terumo BCT, Inc
10811 w. collins ave.
lakewood,  CO  80215 4498
Regulation Number864.9875
Classification Product Code
KSB  
Date Received10/31/2016
Decision Date 11/23/2016
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
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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