510(k) K220378 ยท FXX Mask, Surgical
Sparta 3-Ply Surgical Disposable Face Mask
| Applicant | Sparta East, LLC, Medley FL, US |
| Decision | Substantially Equivalent, Jun 30, 2022 |
| Received | Feb 10, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220378
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.