510(k) K243522 · FYA Gown, Surgical
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| Applicant | Thi Total Healthcare Innovation GmbH, Feistritz Im Rosental, AT |
| Decision | Substantially Equivalent, May 30, 2025 |
| Received | Nov 14, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243522
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.