510(k) K230258 ยท LRC Instrument, Ent Manual Surgical
BB 8 Sinus Dilation Kit
| Applicant | Excelent, Inc., Durham NC, US |
| Decision | Substantially Equivalent, May 25, 2023 |
| Received | Jan 31, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230258
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.