FDA 510(k) Application Details - K993806

Device Classification Name	Subsystem, Water Purification   More FDA Info for this Device
510(K) Number	K993806
Device Name	Subsystem, Water Purification
Applicant	CLARIGEN, INC. 5922 FARNSWORTH COURT CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	EDIT HEGYI 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	11/09/1999
Decision Date	08/14/2000
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