510(k) K153519 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
DReal
| Applicant | Carevature Medical, Ltd., Tel Aviv, IL |
| Decision | Substantially Equivalent, Mar 16, 2016 |
| Received | Dec 8, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153519
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.