FDA 510(k) Application Details - K151368

Device Classification Name	Separator, Automated, Blood Cell And Plasma, Therapeutic   More FDA Info for this Device
510(K) Number	K151368
Device Name	Separator, Automated, Blood Cell And Plasma, Therapeutic
Applicant	TERUMO BCT 10811 W. COLLINS AVENUE LAKEWOOD, CO 80215-4415 US Other 510(k) Applications for this Company
Contact	Nicholas Wong 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	05/21/2015
Decision Date	09/11/2015
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