510(k) K232894 ยท FXX Mask, Surgical
HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124)
| Applicant | Owens & Minor (O&M) Halyard, Inc., Mechanicsville VA, US |
| Decision | Substantially Equivalent, Jan 8, 2024 |
| Received | Sep 18, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232894
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.