FDA 510(k) Application Details - K013345

Device Classification Name	Catheter, Urological   More FDA Info for this Device
510(K) Number	K013345
Device Name	Catheter, Urological
Applicant	HOLLISTER, INC. 2000 HOLLISTER DR. LIBERTYVILLE, IL 60048 US Other 510(k) Applications for this Company
Contact	JOSEPH S TOKARZ Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	KOD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/2001
Decision Date	01/07/2002
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