510(k) K212451 ยท FXX Mask, Surgical
Surgical Mask
| Applicant | Remade USA, LLC, Los Angeles CA, US |
| Decision | Substantially Equivalent, Sep 10, 2021 |
| Received | Aug 5, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212451
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.