510(k) K964548 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
APEX UNIVERSAL DRIVE SYSTEM
| Applicant | Linvatec Corp., Largo FL, US |
| Decision | Substantially Equivalent, Jan 17, 1997 |
| Received | Nov 13, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964548
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.