FDA 510(k) Application Details - K990041

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K990041
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	LABORIE MEDICAL TECH CORP. 310 HURRICANE LN. #2 WILLISTON, VT 05495 US Other 510(k) Applications for this Company
Contact	DALE COLEMAN 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	01/06/1999
Decision Date	08/05/1999
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