510(k) K954989 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
| Applicant | Smith & Nephew Dyonics, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Nov 27, 1995 |
| Received | Oct 31, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954989
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.