510(k) K261949 ยท FYA Gown, Surgical
NYES Tuff Cuff L3 Disposable Gowns
| Applicant | New York Embroidery Studio, Brooklyn NY, US |
| Decision | Substantially Equivalent, Jul 10, 2026 |
| Received | Jun 11, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261949
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.