510(k) K965115 ยท ETD Tube, Tympanostomy
ROUND WINDOW CATH
| Applicant | Neuro-Biometrix, Inc., Denver CO, US |
| Decision | Substantially Equivalent, Mar 10, 1997 |
| Received | Dec 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965115
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.