FDA 510(k) Application Details - K081740

Device Classification Name	Accessories, Blood Circuit, Hemodialysis   More FDA Info for this Device
510(K) Number	K081740
Device Name	Accessories, Blood Circuit, Hemodialysis
Applicant	INNOVATIONS FOR ACCESS, INC. 515 NW SALTZMAN ROAD #797 PORTLAND, OR 97229-6098 US Other 510(k) Applications for this Company
Contact	HAL J OIEN Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	KOC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2008
Decision Date	03/12/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review