510(k) K201545 ยท FXX Mask, Surgical
Surgical Face Mask
| Applicant | Amphastar Nanjing Pharmaceuticals, Inc., Nanjing, CN |
| Decision | Substantially Equivalent, Feb 12, 2021 |
| Received | Jun 9, 2020 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K201545
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.