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
|
|
Correspondent Contact |
E.F. WADDELL |
Regulation Number | 882.4300
|
Classification Product Code |
|
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
|
|
|