510(k) K232777 ยท FXX Mask, Surgical
FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)
| Applicant | Owens & Minor (O&M) Halyard, Inc., Mechanicsville VA, US |
| Decision | Substantially Equivalent, Jul 1, 2024 |
| Received | Sep 11, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232777
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.