510(k) K202697 ยท FXX Mask, Surgical
United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask
| Applicant | United Sewing Automation, Inc., Mount Airy NC, US |
| Decision | Substantially Equivalent, May 13, 2021 |
| Received | Sep 16, 2020 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K202697
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.