FDA 510(k) Application Details - K033256

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K033256
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	ATHENA FEMININE TECHNOLOGIES, INC. 179 MORAGA WAY ORINDA, CA 94563-3442 US Other 510(k) Applications for this Company
Contact	BARBARA SARKIS 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	10/09/2003
Decision Date	12/30/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review