FDA 510(k) Application Details - K092481

Device Classification Name	Subsystem, Water Purification   More FDA Info for this Device
510(K) Number	K092481
Device Name	Subsystem, Water Purification
Applicant	NEW AQUA LLC (DBA AQUA SYSTEMS) 114 VISTA PARKWAY AVON, IN 46123 US Other 510(k) Applications for this Company
Contact	NEVIN RUDIE 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	08/13/2009
Decision Date	04/02/2010
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