510(k) K203418 ยท FXX Mask, Surgical
Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))
| Applicant | Ningbo Ouhan Medical Device Co., Ltd., Yuyao City, CN |
| Decision | Substantially Equivalent, Sep 17, 2021 |
| Received | Nov 19, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203418
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.