510(k) K212097 ยท FXX Mask, Surgical
Disposable medical surgical mask
| Applicant | Hebei Titans Hongsen Medical Technology Co., Ltd., Xingtai, CN |
| Decision | Substantially Equivalent, Aug 18, 2021 |
| Received | Jul 6, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212097
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.