510(k) K201182 ยท FXX Mask, Surgical
iMask Disposable Surgical Face Mask
| Applicant | Pac-Dent, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Feb 19, 2021 |
| Received | May 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201182
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.