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FDA 510(k) Application Details - K131744
Device Classification Name
Separator, Automated, Blood Cell And Plasma, Therapeutic
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510(K) Number
K131744
Device Name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Applicant
TERUMO BCT, INC..
10811 WEST COLLINS AVE.
LAKEWOOD, CO 80215 US
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Contact
TINA O'BRIEN
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LKN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/13/2013
Decision Date
08/08/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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