510(k) K230395 ยท FXX Mask, Surgical
Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)
| Applicant | Durio Ppe Sdn Bhd, Johor Bahru, MY |
| Decision | Substantially Equivalent, Jul 17, 2023 |
| Received | Feb 14, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230395
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.