510(k) K203548 · FYA Gown, Surgical
EndoArmor + Surgical Gown
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Feb 21, 2022 |
| Received | Dec 4, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203548
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.