FDA 510(k) Application Details - K961904

Device Classification Name	Dilator, Urethral   More FDA Info for this Device
510(K) Number	K961904
Device Name	Dilator, Urethral
Applicant	COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 SPENCER, IN 47460 US Other 510(k) Applications for this Company
Contact	TAMMY BACON Other 510(k) Applications for this Contact
Regulation Number	876.5520   More FDA Info for this Regulation Number
Classification Product Code	KOE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/1996
Decision Date	10/18/1996
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