FDA 510(k) Application Details - K131229

Device Classification Name	More FDA Info for this Device
510(K) Number	K131229
Device Name	SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
Applicant	AMERICAN MEDICAL SYSTEMS 10700 BREN ROAD WEST MINNETONKA, MN 55343 US Other 510(k) Applications for this Company
Contact	TODD HILDEBRANDT 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	04/30/2013
Decision Date	12/05/2013
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