510(k) K130755 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
HICUT HIGHSPEED INSTRUMENT
| Applicant | Adeor Medical AG, Pullach, DE |
| Decision | Substantially Equivalent, Jun 27, 2014 |
| Received | Mar 19, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130755
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.