510(k) K251860 ยท FYA Gown, Surgical
Copioumed AAMI 3 Surgical Gown
| Applicant | Copioumed International, Inc., Taipei City, TW |
| Decision | Substantially Equivalent, Feb 26, 2026 |
| Received | Jun 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251860
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.