FDA 510(k) Application Details - K082640

Device Classification Name	More FDA Info for this Device
510(K) Number	K082640
Device Name	VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM
Applicant	COLOPLAST MANUFACTURING US, LLC 1499 WEST RIVER ROAD NORTH MINNEAPOLIS, MN 55411 US Other 510(k) Applications for this Company
Contact	ANGELA BYLAND Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2008
Decision Date	10/17/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review