510(k) K221534 ยท FXX Mask, Surgical
Surgical Face Masks (Ear Loops And Tie-On)
| Applicant | San-M Package Co., Ltd., Shimada-City, JP |
| Decision | Substantially Equivalent, Sep 16, 2022 |
| Received | May 27, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221534
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.