FDA 510(k) Application Details - K161566

Device Classification Name	Electrode, Needle   More FDA Info for this Device
510(K) Number	K161566
Device Name	Electrode, Needle
Applicant	Daehan Medical Systems Co., Ltd. 250 Okgucheondong-Ro Siheung City 15084 KR Other 510(k) Applications for this Company
Contact	Dong Cheul Kim Other 510(k) Applications for this Contact
Regulation Number	882.1350   More FDA Info for this Regulation Number
Classification Product Code	GXZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2016
Decision Date	12/21/2016
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