The following data is part of a premarket notification filed by Mri Interventions, Inc. with the FDA for Mrii Cranial Drill And Accessories.
| Device ID | K160129 |
| 510k Number | K160129 |
| Device Name: | MRII Cranial Drill And Accessories |
| Classification | Drills, Burrs, Trephines & Accessories (manual) |
| Applicant | MRI INTERVENTIONS, INC. 5 MUSICK Irvine, CA 92618 |
| Contact | Peter Piferi |
| Correspondent | Peter Piferi MRI INTERVENTIONS, INC. 5 MUSICK Irvine, CA 92618 |
| Product Code | HBG |
| CFR Regulation Number | 882.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-20 |
| Decision Date | 2016-03-26 |
| Summary: | summary |