FDA 510(k) Application Details - K972054

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K972054
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	EMPI 599 CARDIGAN RD. ST. PAUL, MN 55126 US Other 510(k) Applications for this Company
Contact	CAROLYN M STEELE HUSTEN 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	06/02/1997
Decision Date	08/14/1997
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