The following data is part of a premarket notification filed by Mri Interventions, Inc. with the FDA for Smarttwist Mrii Hand Drill, Smarttip Mrii Drill Bit Kit, 4.5mm, 6.0mm.
| Device ID | K151536 |
| 510k Number | K151536 |
| Device Name: | SmartTwist MRII Hand Drill, SmartTip MRII Drill Bit Kit, 4.5mm, 6.0mm |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-08 |
| Decision Date | 2015-07-08 |
| Summary: | summary |