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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 BK070018
Tradename TRUCISE Total System
Device Name Set, Transfer (Blood/Plasma)
Original Applicant
Terumo Medical Corporation
125 blue ball road
elkton,  MD  21921
Regulation Number864.9875
Classification Product Code
KSB  
Date Received04/16/2007
Decision Date 01/22/2008
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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