FDA 510(k) Application Details - K012850

Device Classification Name	Electrode, Depth   More FDA Info for this Device
510(K) Number	K012850
Device Name	Electrode, Depth
Applicant	RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP 22 TERRY AVE. BURLINGTON, MA 01803 US Other 510(k) Applications for this Company
Contact	KEVIN J O'CONNELL 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	08/24/2001
Decision Date	11/19/2001
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