FDA 510(k) Application Details - K962009

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K962009
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	LABORIE MEDICAL TECHNOLOGIES, LTD. 7 GREEN TREE DR. SOUTH BURLINGTON, VT 05403 US Other 510(k) Applications for this Company
Contact	MIKE BARRE 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	05/22/1996
Decision Date	05/20/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review