FDA 510(k) Application Details - K132561

Device Classification Name	Stimulator,Peripheral Nerve,Non-Implanted,For Pelvic Floor Dysfunction   More FDA Info for this Device
510(K) Number	K132561
Device Name	Stimulator,Peripheral Nerve,Non-Implanted,For Pelvic Floor Dysfunction
Applicant	ADVANCED URO-SOLUTIONS, INC. 717 LAKEGLEN DRIVE SUWANEE, GA 30024 US Other 510(k) Applications for this Company
Contact	PENNY NORTHCUTT Other 510(k) Applications for this Contact
Regulation Number	876.5310   More FDA Info for this Regulation Number
Classification Product Code	NAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2013
Decision Date	11/05/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review