510(k) K203237 ยท FYA Gown, Surgical
Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown
| Applicant | Dukal Corporation, Ronkonkoma NY, US |
| Decision | Substantially Equivalent, Mar 18, 2022 |
| Received | Nov 3, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203237
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.