510(k) K232806 ยท FXX Mask, Surgical
HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)
| Applicant | Owens & Minor (O&M) Halyard, Inc., Mechanicsville VA, US |
| Decision | Substantially Equivalent, Jun 7, 2024 |
| Received | Sep 12, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232806
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.