FDA 510(k) Application Details - K163355

Device Classification Name	Electrode, Depth   More FDA Info for this Device
510(K) Number	K163355
Device Name	Electrode, Depth
Applicant	Ad-Tech Medical Instrument Corporation 1901 William Street Racine, WI 53404 US Other 510(k) Applications for this Company
Contact	Lisa Theama Other 510(k) Applications for this Contact
Regulation Number	882.1330   More FDA Info for this Regulation Number
Classification Product Code	GZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2016
Decision Date	04/12/2017
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