510(k) K230380 ยท FXX Mask, Surgical
Surgical Face Masks, Model: EFMDS-L50Pn BLU
| Applicant | Iris USA, Pleasant Prairie WI, US |
| Decision | Substantially Equivalent, Aug 3, 2023 |
| Received | Feb 13, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230380
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.