MRII CRAINIAL DRILL


Device Classification Name

drills, burrs, trephines & accessories (manual)

510(k) Number K122456
Device Name MRII CRAINIAL DRILL
Applicant
MRI INTERVENTIONS, INC.
5 musick
irvine, 
CA 
92618

Applicant Contact e.f. waddell
Correspondent
MRI INTERVENTIONS, INC.
5 musick
irvine, 
CA 
92618

Correspodent Contact e.f. waddell
Regulation Number 882.4300
Classification Product Code
HBG  
Date Received 08/13/2012
Decision Date 03/22/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No