FDA 510(k) Application Details - K972977

Device Classification Name	Accessories, Catheter, G-U   More FDA Info for this Device
510(K) Number	K972977
Device Name	Accessories, Catheter, G-U
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	876.5130   More FDA Info for this Regulation Number
Classification Product Code	KNY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/1997
Decision Date	10/10/1997
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