BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇬🇧 United Kingdom

    BIOBRANE Temporary Wound Dressing; BIOBRANE Glove

    K Number: K242146 · Decision Dec 17, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    19
    Review Days
    147

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    Basic Information

    Device Name
    BIOBRANE Temporary Wound Dressing; BIOBRANE Glove
    K Number
    K242146
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Medical Limited
    Date Received
    July 23, 2024
    Decision Date
    December 17, 2024
    Product Code
    KGN
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KGN Wound Dressing With Animal-Derived Material(S)

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