The following data is part of a premarket notification filed by Mri Interventions, Inc. with the FDA for Mrii Crainial Drill.
| Device ID | K122456 |
| 510k Number | K122456 |
| Device Name: | MRII CRAINIAL DRILL |
| Classification | Drills, Burrs, Trephines & Accessories (manual) |
| Applicant | MRI INTERVENTIONS, INC. 5 MUSICK Irvine, CA 92618 |
| Contact | E.f. Waddell |
| Correspondent | E.f. Waddell MRI INTERVENTIONS, INC. 5 MUSICK Irvine, CA 92618 |
| Product Code | HBG |
| CFR Regulation Number | 882.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-13 |
| Decision Date | 2013-03-22 |
| Summary: | summary |