FDA 510(k) Application Details - K113480

Device Classification Name	Separator, Automated, Blood Cell And Plasma, Therapeutic   More FDA Info for this Device
510(K) Number	K113480
Device Name	Separator, Automated, Blood Cell And Plasma, Therapeutic
Applicant	CARIDIANBCT, INC. 10811 W. COLLINS AVE LAKEWOOD, CO 80215 US Other 510(k) Applications for this Company
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	11/23/2011
Decision Date	01/20/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review