510(k) K213427 ยท OXZ Pediatric/Child Facemask
PRIMED Pediatric Facemask
| Applicant | Primed Medical Products, Inc., Edmonton, CA |
| Decision | Substantially Equivalent, Nov 22, 2022 |
| Received | Oct 21, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213427
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.