FDA 510(k) Application Details - K971015

Device Classification Name	Apparatus, Hemoperfusion, Sorbent   More FDA Info for this Device
510(K) Number	K971015
Device Name	Apparatus, Hemoperfusion, Sorbent
Applicant	AMERICAN HEALTH CARE SYSTEMS, INC. 3350 RIDGELAKE AVE., SUITE 255 METAIRIE, LA 70002 US Other 510(k) Applications for this Company
Contact	EARL G SCHMIT 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	03/20/1997
Decision Date	10/22/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review