FDA 510(k) Application Details - K992196

Device Classification Name	Apparatus, Hemoperfusion, Sorbent   More FDA Info for this Device
510(K) Number	K992196
Device Name	Apparatus, Hemoperfusion, Sorbent
Applicant	HEMOCLEANSE, INC. 2700 KENT AVE. WEST LAFAYETTE, IN 47906 US Other 510(k) Applications for this Company
Contact	STEPHEN R ASH 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	06/30/1999
Decision Date	09/10/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review