FDA 510(k) Application Details - K981344

Device Classification Name	Catheter, Nephrostomy   More FDA Info for this Device
510(K) Number	K981344
Device Name	Catheter, Nephrostomy
Applicant	URESIL CORP. 5418 W. TOUHY AVE. SKOKIE, IL 60077 US Other 510(k) Applications for this Company
Contact	LEV MELINYSHYN 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	04/09/1998
Decision Date	09/10/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review