FDA 510(k) Application Details - K980182

Device Classification Name	Subsystem, Water Purification   More FDA Info for this Device
510(K) Number	K980182
Device Name	Subsystem, Water Purification
Applicant	U.S. FILTER/IONPURE, INC. 10 TECHNOLOGY DR. LOWELL, MA 01851 US Other 510(k) Applications for this Company
Contact	CHERYL ARDIZZONI 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	01/20/1998
Decision Date	11/16/1998
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