510(k) K161376 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
DragonFly Surgical Drill System
| Applicant | Grace Medical, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Aug 25, 2016 |
| Received | May 18, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161376
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.