FDA 510(k) Application Details - K981085

Device Classification Name	Subsystem, Water Purification   More FDA Info for this Device
510(K) Number	K981085
Device Name	Subsystem, Water Purification
Applicant	GAMBRO HEALTHCARE 1185 OAK ST. LAKEWOOD, CO 80215-4498 US Other 510(k) Applications for this Company
Contact	WILLIAM M TOWNSEND Other 510(k) Applications for this Contact
Regulation Number	876.5665   More FDA Info for this Regulation Number
Classification Product Code	FIP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/25/1998
Decision Date	05/18/1998
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