510(k) K253816 ยท OLR Oral Wound Dressing
MuCover (proposed name) Oral Wound Dressing
| Applicant | MoleculeX Co., Ltd., Hsinchu, TW |
| Decision | Substantially Equivalent, May 21, 2026 |
| Received | Nov 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253816
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.