510(k) K211066 ยท FXX Mask, Surgical
Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3
| Applicant | Homtex, Inc., Cullman AL, US |
| Decision | Substantially Equivalent, Aug 19, 2021 |
| Received | Apr 12, 2021 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K211066
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.