FDA 510(k) Application Details - K053007

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K053007
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	SKYLARK DEVICE & SYSTEMS CO., LTD 4F, 34, SEC. 3, CHUNG SHAN NORTH RD. TAIPEI 104 TW Other 510(k) Applications for this Company
Contact	GEORGE CHIANG 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	10/26/2005
Decision Date	12/05/2005
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