510(k) K212302 ยท FXX Mask, Surgical
BAYLAB 3-Ply Surgical Mask (BEACON I)
| Applicant | Baylab USA, LLC, Dallas TX, US |
| Decision | Substantially Equivalent, Dec 7, 2021 |
| Received | Jul 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212302
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.