510(k) K212863 ยท FXX Mask, Surgical
Surgical Face Mask
| Applicant | Taiwan Comfort Champ Manufacturing Co., Ltd., Taoyuan City, TW |
| Decision | Substantially Equivalent, Feb 19, 2022 |
| Received | Sep 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212863
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.