510(k) K213893 ยท FYA Gown, Surgical
Comfort Gown, Safewear Gown
| Applicant | Xuchang Zhengde Environstar Medical Products Co., Ltd., Xuchang, CN |
| Decision | Substantially Equivalent, Dec 21, 2022 |
| Received | Dec 14, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213893
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.