510(k) K203539 ยท FYA Gown, Surgical
Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)
| Applicant | Unicoglobal, Inc., Seongnam, KR |
| Decision | Substantially Equivalent, Dec 10, 2021 |
| Received | Dec 3, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203539
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.