FDA 510(k) Application Details - K161055

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K161055
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	Fuji Dynamics Ltd 1-3, 23/F., Laws Commercial Plaza, 788 Cheung Sha Wan Road Hong Kong CN Other 510(k) Applications for this Company
Contact	Kam Tim Ng 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	04/14/2016
Decision Date	07/12/2016
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