510(k) K151536 ยท HBG Drills, Burrs, Trephines & Accessories (Manual)
SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm
| Applicant | Mri Interventions, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jul 8, 2015 |
| Received | Jun 8, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K151536
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.