FDA 510(k) Application Details - K142369

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K142369
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD F19, NO. 1 KESHENG ROAD, BAIYUN TORCH, BUILDING, NO. 1633 BEITAI RAOD,BAIYUN GUANGZHOU 510040 CN Other 510(k) Applications for this Company
Contact	Chiping Ma 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	08/25/2014
Decision Date	06/17/2015
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