510(k) K211097 ยท FXX Mask, Surgical
Banyan USA Surgical Mask Level 3
| Applicant | Banyan USA, LLC, Hauppauge NY, US |
| Decision | Substantially Equivalent, Sep 22, 2021 |
| Received | Apr 13, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211097
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.