FDA 510(k) Application Details - K002154

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K002154
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	EMD ELECTRONIC MEDICAL DEVICES, CORP. 1621 BAY ROAD, SUITE 908 MIAMI BEACH, FL 33139-3260 US Other 510(k) Applications for this Company
Contact	JEAN CLAUDE MARTY Other 510(k) Applications for this Contact
Regulation Number	876.5320   More FDA Info for this Regulation Number
Classification Product Code	KPI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/17/2000
Decision Date	03/22/2001
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