K253816
- 510(k) number
- K253816
- Device name
- MuCover (proposed name) Oral Wound Dressing
- Applicant
- MoleculeX Co., Ltd. TW
- Product code
- OLR — Oral Wound Dressing
- Decision date
- 2026-05-21
- Date received
- 2025-11-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253816.pdf
Official FDA record: K253816
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.