510(k) K232807 ยท FXX Mask, Surgical
Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)
| Applicant | Owens & Minor (O&M) Halyard, Inc., Mechanicsville VA, US |
| Decision | Substantially Equivalent, Jun 21, 2024 |
| Received | Sep 12, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232807
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.