510(k) K210147 ยท FXX Mask, Surgical
Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield
| Applicant | Unicoglobal, Inc., Seongnam, KR |
| Decision | Substantially Equivalent, Dec 22, 2021 |
| Received | Jan 21, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210147
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.