510(k) K201351 ยท FYA Gown, Surgical
Maxima Surgical Gown
| Applicant | Elevate Textiles, Mt. Holly NC, US |
| Decision | Substantially Equivalent, Mar 11, 2022 |
| Received | May 21, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201351
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.