FDA 510(k) Application Details - K080386

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K080386
Device Name	Electrode, Cutaneous
Applicant	COLUMBIA SCIENTIFIC DEVELOPMENT LLC 420 NW 11TH AVENUE SUITE 617 PORTLAND, OR 97209 US Other 510(k) Applications for this Company
Contact	STEPHEN SHULMAN Other 510(k) Applications for this Contact
Regulation Number	882.1320   More FDA Info for this Regulation Number
Classification Product Code	GXY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2008
Decision Date	05/30/2008
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	Y
Expedited Review