FDA 510(k) Application Details - K122456

Device Classification Name	Drills, Burrs, Trephines & Accessories (Manual)   More FDA Info for this Device
510(K) Number	K122456
Device Name	Drills, Burrs, Trephines & Accessories (Manual)
Applicant	MRI INTERVENTIONS, INC. 5 MUSICK IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	E.F. WADDELL Other 510(k) Applications for this Contact
Regulation Number	882.4300   More FDA Info for this Regulation Number
Classification Product Code	HBG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/2012
Decision Date	03/22/2013
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