510(k) K202595 ยท FXX Mask, Surgical
Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask
| Applicant | Premier Guard USA, LLC, Jackson MS, US |
| Decision | Substantially Equivalent, Jan 21, 2021 |
| Received | Sep 8, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202595
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.