FDA 510(k) Application Details - K101297

Device Classification Name	More FDA Info for this Device
510(K) Number	K101297
Device Name	VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020
Applicant	COLOPLAST A/S 1601 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	05/10/2010
Decision Date	06/03/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review