FDA 510(k) Application Details - K012716

Device Classification Name	System, Water Purification, General Medical Use   More FDA Info for this Device
510(K) Number	K012716
Device Name	System, Water Purification, General Medical Use
Applicant	PRISMEDICAL CORP. 1100 TRANCAS ST., STE. 250 NAPA, CA 94558 US Other 510(k) Applications for this Company
Contact	ELAINE ALAMBRA Other 510(k) Applications for this Contact
Regulation Number	876.5665   More FDA Info for this Regulation Number
Classification Product Code	NHV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2001
Decision Date	05/07/2002
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