FDA 510(k) Application Details - K161715

Device Classification Name	Media, Electroconductive   More FDA Info for this Device
510(K) Number	K161715
Device Name	Media, Electroconductive
Applicant	EndyMed Medical Ltd. 12 Leshem Street, North Industrial Park Caesarea 3088900 IL Other 510(k) Applications for this Company
Contact	Yoram Levy Other 510(k) Applications for this Contact
Regulation Number	882.1275   More FDA Info for this Regulation Number
Classification Product Code	GYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2016
Decision Date	02/07/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review