510(k) K201095 ยท FXX Mask, Surgical
Sovereign America Surgical Face Mask
| Applicant | Homtex, Inc., Cullman AL, US |
| Decision | Substantially Equivalent, Mar 19, 2021 |
| Received | Apr 24, 2020 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K201095
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.