FDA 510(k) Application Details - K071496

Device Classification Name	Kit, Catheter, Urinary (Exludes Hiv Testing)   More FDA Info for this Device
510(K) Number	K071496
Device Name	Kit, Catheter, Urinary (Exludes Hiv Testing)
Applicant	COLORADO CATHETER COMPANY, INC. 15975 WINDING TRAIL ROAD COLORADO SPRINGS, CO 80908 US Other 510(k) Applications for this Company
Contact	DOUG WILSON Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	NWO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2007
Decision Date	08/15/2007
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review