510(k) K812675 ยท FXX Mask, Surgical
DISPOSABLE SURGICAL FACE MASKS
| Applicant | Irema USA , Ltd., Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 13, 1981 |
| Received | Sep 22, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812675
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.