510(k) K212869 ยท FYA Gown, Surgical
Disposable Surgical Gown, Disposable Reinforced Surgical Gown
| Applicant | Fugou County Shenxiang Manufacturing Co., Ltd., Zhoukou, CN |
| Decision | Substantially Equivalent, Dec 13, 2021 |
| Received | Sep 9, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212869
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.