510(k) K160269 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 6, 2016 |
| Received | Feb 2, 2016 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K160269
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.