FDA 510(k) Application Details - K132655

Device Classification Name	More FDA Info for this Device
510(K) Number	K132655
Device Name	RETROARC RETROPUBIC SLING SYSTEM
Applicant	AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST MINNETONKA, MN 55343 US Other 510(k) Applications for this Company
Contact	RENEE MELLUM Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/2013
Decision Date	11/20/2013
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