510(k) K984035 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
XK-95 HIGH SPEED MOTOR DRILL SYSTEM
| Applicant | Komet Medical, Atlanta GA, US |
| Decision | Substantially Equivalent, Jun 3, 1999 |
| Received | Nov 12, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984035
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.