510(k) K210767 ยท FXX Mask, Surgical
Surgical Masks, Model:FE-1
| Applicant | Hunan Triplex Precision Medical Devices Co., Ltd., Changsha, CN |
| Decision | Substantially Equivalent, Jun 10, 2021 |
| Received | Mar 15, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210767
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.