510(k) K232849 ยท FYC Gown, Isolation, Surgical
Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
| Applicant | Owens & Minor (O&M) Halyard, Inc., Mechanicsville VA, US |
| Decision | Substantially Equivalent, May 16, 2024 |
| Received | Sep 14, 2023 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K232849
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.