FDA 510(k) Application Details - K032988

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K032988
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	DANMETER A/S KILDEMOSEVEJ 13 ODENSE C DK-5000 DK Other 510(k) Applications for this Company
Contact	HANNE NIELSEN 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	09/24/2003
Decision Date	12/03/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review