FDA 510(k) Application Details - K113313

Device Classification Name	Apparatus, Hemoperfusion, Sorbent   More FDA Info for this Device
510(K) Number	K113313
Device Name	Apparatus, Hemoperfusion, Sorbent
Applicant	GAMBRO RENAL PRODUCTS, INC. 14143 DENVER WEST PARKWAY SUITE 400 LAKEWOOD, CO 80401 US Other 510(k) Applications for this Company
Contact	KAE MILLER Other 510(k) Applications for this Contact
Regulation Number	876.5870   More FDA Info for this Regulation Number
Classification Product Code	FLD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2011
Decision Date	12/14/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review