FDA 510(k) Application Details - K112331

Device Classification Name	Subsystem, Water Purification   More FDA Info for this Device
510(K) Number	K112331
Device Name	Subsystem, Water Purification
Applicant	ARION WATER, INC. 1 COMMERCE WAY BLDG 1 UNIT C CARVER, MA 02330 US Other 510(k) Applications for this Company
Contact	ROBERT LIVINGSTION 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	08/12/2011
Decision Date	07/05/2012
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