510(k) K220194 ยท FXX Mask, Surgical
Procedure mask/Surgical mask/Face mask
| Applicant | Winner Medical Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, May 17, 2022 |
| Received | Jan 24, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220194
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.