FDA 510(k) Application Details - K072808

Device Classification Name	Catheter, Urethral   More FDA Info for this Device
510(K) Number	K072808
Device Name	Catheter, Urethral
Applicant	COLOPLAST CORP. 1601 WEST RIVER N MINNEAPOLIS, MN 55411 US Other 510(k) Applications for this Company
Contact	REBEKA STOLTMAN 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	10/01/2007
Decision Date	11/09/2007
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