FDA 510(k) Application Details - K083712

Device Classification Name	Subsystem, Water Purification   More FDA Info for this Device
510(K) Number	K083712
Device Name	Subsystem, Water Purification
Applicant	DIPURE, LLC. 1919 EDWARDS STREET HOUSTON, TX 77007 US Other 510(k) Applications for this Company
Contact	TIM MARCO 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	12/15/2008
Decision Date	07/10/2009
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