FDA 510(k) Application Details - K163288

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K163288
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	Shenzhen Konmed Technology Co., Ltd. 703B, Haide building A, Nanxin Road, Nanshan Shenzhen 518000 CN Other 510(k) Applications for this Company
Contact	Tony Tony 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	11/22/2016
Decision Date	01/18/2018
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