FDA 510(k) Application Details - K994109

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K994109
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	INNOVAMED USA, INC. 1140 LEE BLVD., SUITE 101-103 LEHIGH ACRES, FL 33936 US Other 510(k) Applications for this Company
Contact	E.H. CZADILEK 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	12/06/1999
Decision Date	08/03/2000
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