510(k) K202615 ยท FXX Mask, Surgical
Nordiwell Medical Face Mask
| Applicant | Changzhou Combat Protective Equipment Co., Ltd., Changzhou, CN |
| Decision | Substantially Equivalent, Dec 31, 2020 |
| Received | Sep 9, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202615
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.