510(k) K212861 ยท FYA Gown, Surgical
Surgical Gown, Reinforced Surgical Gown
| Applicant | Wuhan Zonsen Medical Products Co., Ltd., Wuhan, CN |
| Decision | Substantially Equivalent, Dec 15, 2021 |
| Received | Sep 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212861
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.