510(k) K213406 ยท FXX Mask, Surgical
Savvy Mask - Level 3 Surgical Face Mask
| Applicant | Texas Medplast, LLC, Houston TX, US |
| Decision | Substantially Equivalent, Nov 18, 2021 |
| Received | Oct 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213406
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.