FDA 510(k) Application Details - K090960

Device Classification Name	Catheter, Urethral   More FDA Info for this Device
510(K) Number	K090960
Device Name	Catheter, Urethral
Applicant	HOLLISTER, INC. 2000 HOLLISTER DR. LIBERTYVILLE, IL 60048 US Other 510(k) Applications for this Company
Contact	CHRIS STUKEL Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	GBM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2009
Decision Date	08/20/2009
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