FDA 510(k) Application Details - K102802

Device Classification Name	Electrode, Cortical   More FDA Info for this Device
510(K) Number	K102802
Device Name	Electrode, Cortical
Applicant	INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 US Other 510(k) Applications for this Company
Contact	DEREK CAO 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	09/27/2010
Decision Date	11/23/2010
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