510(k) K212717 ยท FYC Gown, Isolation, Surgical
Paneffort AAMI Level 3 Isolation Gown
| Applicant | Paneffort, LLC, Rochester, NY, US |
| Decision | Substantially Equivalent, Nov 30, 2022 |
| Received | Aug 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212717
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.