FDA 510(k) Application Details - K101847

Device Classification Name	Stimulator,Peripheral Nerve,Non-Implanted,For Pelvic Floor Dysfunction   More FDA Info for this Device
510(K) Number	K101847
Device Name	Stimulator,Peripheral Nerve,Non-Implanted,For Pelvic Floor Dysfunction
Applicant	UROPLASTY, INC. 5420 FELTL RD. MINNETONKA, MN 55343 US Other 510(k) Applications for this Company
Contact	MICHAEL MORRELL 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	07/01/2010
Decision Date	10/21/2010
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