510(k) K945659 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
BLACKSTAR(TM) STAR SYSTEM
| Applicant | Xomed-Treace, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Jan 9, 1995 |
| Received | Nov 17, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945659
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.