FDA 510(k) Application Details - DEN000002

Device Classification Name	Stimulator,Peripheral Nerve,Non-Implanted,For Pelvic Floor Dysfunction   More FDA Info for this Device
510(K) Number	DEN000002
Device Name	Stimulator,Peripheral Nerve,Non-Implanted,For Pelvic Floor Dysfunction
Applicant	UROSURGE, INC. 2660 CROSSPARK RD. CORALVILLE, IA 52241 US Other 510(k) Applications for this Company
Contact	STEVEN J PREISS 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	01/27/2000
Decision Date	02/09/2000
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review