510(k) K252964 ยท FXX Mask, Surgical
PRIMED Surgical and Procedure Masks
| Applicant | Primed Medical Products, Inc., Edmonton, CA |
| Decision | Substantially Equivalent, Nov 4, 2025 |
| Received | Sep 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252964
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.