510(k) K212504 ยท FYC Gown, Isolation, Surgical
Isolation Gown AAMI Level 3
| Applicant | Kenpax International Limited, Hong Kong, CN |
| Decision | Substantially Equivalent, Nov 7, 2021 |
| Received | Aug 9, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212504
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.