FDA 510(k) Application Details - K161654

Device Classification Name	Media, Electroconductive   More FDA Info for this Device
510(K) Number	K161654
Device Name	Media, Electroconductive
Applicant	Carol Cole Company 1325 Sycamore Avenue, Suite A Vista, CA 92081 US Other 510(k) Applications for this Company
Contact	Merle Kovacic 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	06/15/2016
Decision Date	12/30/2016
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