FDA 510(k) Application Details - K082629

Device Classification Name	Electrode, Cortical   More FDA Info for this Device
510(K) Number	K082629
Device Name	Electrode, Cortical
Applicant	CHATTEN ASSOCIATES, INC. 1094 NEW DEHAVEN AVE SUITE 200 WEST CONSHOHOCKEN, PA 19428 US Other 510(k) Applications for this Company
Contact	JOHN B CHATTEN Other 510(k) Applications for this Contact
Regulation Number	882.1310   More FDA Info for this Regulation Number
Classification Product Code	GYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2008
Decision Date	07/01/2009
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