FDA 510(k) Application Details - K061782

Device Classification Name	Subsystem, Water Purification   More FDA Info for this Device
510(K) Number	K061782
Device Name	Subsystem, Water Purification
Applicant	GAMBRO SERVICES, INC. 7307 GLOUCHESTER DRIVE EDINA, MN 55435 US Other 510(k) Applications for this Company
Contact	JEFFERY R SHIDEMAN 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	06/26/2006
Decision Date	01/04/2007
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