510(k) K232293 · IYE Accelerator, Linear, Medical
kallisio stentra oral stent
| Applicant | Kallisio, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Dec 22, 2023 |
| Received | Aug 1, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232293
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.