FDA 510(k) Application Details - K080944

Device Classification Name	Catheter, Nephrostomy   More FDA Info for this Device
510(K) Number	K080944
Device Name	Catheter, Nephrostomy
Applicant	C.R. BARD, INC. 13183 HARLAND DRIVE COVINGTON, GA 30014-2655 US Other 510(k) Applications for this Company
Contact	TERRI MORRIS Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LJE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2008
Decision Date	10/23/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review