FDA 510(k) Application Details - K111881

Device Classification Name	More FDA Info for this Device
510(K) Number	K111881
Device Name	VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT
Applicant	COLOPLAST A/S 1601 WEST RIVER ROAD N MINNEAPOLIS, MN 55411 US Other 510(k) Applications for this Company
Contact	JANELL A COLLEY 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	07/01/2011
Decision Date	08/17/2011
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