BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇹🇼 Taiwan

    MuCover (proposed name) Oral Wound Dressing

    K Number: K253816 · Decision May 21, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    40
    Applicant Total
    1
    Review Days
    174

    Basic Information

    Device Name
    MuCover (proposed name) Oral Wound Dressing
    K Number
    K253816
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MoleculeX Co., Ltd.
    Date Received
    November 28, 2025
    Decision Date
    May 21, 2026
    Product Code
    OLR
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OLR Oral Wound Dressing

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