FDA 510(k) Application Details - K100807

Device Classification Name	More FDA Info for this Device
510(K) Number	K100807
Device Name	MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191
Applicant	AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST MINNETONKA, MN 55343 US Other 510(k) Applications for this Company
Contact	DONNA SEMLAK Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PAH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2010
Decision Date	06/07/2010
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