510(k) K211399 ยท FYA Gown, Surgical
Sterile Level 3 Surgical Gown
| Applicant | Barco Tekstil Sanayi VE Ticaret A.S., Istanbul, TR |
| Decision | Substantially Equivalent, Jul 22, 2022 |
| Received | May 5, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211399
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.