FDA 510(k) Application Details - K962921

Device Classification Name	Dilator, Catheter, Ureteral   More FDA Info for this Device
510(K) Number	K962921
Device Name	Dilator, Catheter, Ureteral
Applicant	C.R. BARD, INC. 8195 INDUSTRIAL BLVD. COVINGTON, GA 30014 US Other 510(k) Applications for this Company
Contact	DONNA J WILSON Other 510(k) Applications for this Contact
Regulation Number	876.5470   More FDA Info for this Regulation Number
Classification Product Code	EZN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/1996
Decision Date	10/09/1996
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