FDA 510(k) Application Details - K970674

Device Classification Name	Tank, Holding, Dialysis   More FDA Info for this Device
510(K) Number	K970674
Device Name	Tank, Holding, Dialysis
Applicant	G.E.M. WATER SYSTEMS 5940 LAKESHORE DR. CYPRESS, CA 90630 US Other 510(k) Applications for this Company
Contact	JACK ENKOWITZ Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FIN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/1997
Decision Date	11/19/1997
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