BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    BARLE TISSUE ADHESIVE

    K Number: K123133 · Decision May 22, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    35
    Applicant Total
    5
    Review Days
    230

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    Basic Information

    Device Name
    BARLE TISSUE ADHESIVE
    K Number
    K123133
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Medical Solutions (Plymouth), Ltd.
    Date Received
    October 4, 2012
    Decision Date
    May 22, 2013
    Product Code
    MPN
    Advisory Committee
    General, Plastic Surgery
    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
    MPN Tissue Adhesive For The Topical Approximation Of Skin

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    Other Clearances by Advanced Medical Solutions (Plymouth), Ltd.

    K Number Device Name
    K151182 LiquiBand Exceed
    K133443 MARATHON NO STING LIQUID SKIN PROTECTANT
    K132243 BARLE TISSUE ADHESIVE 2
    K122446 LIQUIDBAND FLOW CONTROL