FDA 510(k) Application Details - K071364

Device Classification Name	Electrode, Depth   More FDA Info for this Device
510(K) Number	K071364
Device Name	Electrode, Depth
Applicant	FHC, INC. 1201 MAIN ST BOWDOIN, ME 04287 US Other 510(k) Applications for this Company
Contact	LEE D MARGOLIN 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	05/16/2007
Decision Date	07/25/2007
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