510(k) K230577 ยท FYA Gown, Surgical
Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
| Applicant | Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi, Izmir, TR |
| Decision | Substantially Equivalent, Aug 16, 2023 |
| Received | Mar 1, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230577
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.