FDA 510(k) Application Details - K032054

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K032054
Device Name	Neurological Stereotaxic Instrument
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	882.4560   More FDA Info for this Regulation Number
Classification Product Code	HAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2003
Decision Date	09/15/2003
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