BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    CM005 Standard (CM005); CM004 Mini (CM004)

    K Number: K233458 · Decision Jul 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    266

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    Basic Information

    Device Name
    CM005 Standard (CM005); CM004 Mini (CM004)
    K Number
    K233458
    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
    Connexicon Medical , Ltd.
    Date Received
    October 23, 2023
    Decision Date
    July 15, 2024
    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 Connexicon Medical , Ltd.

    K Number Device Name
    K233460 CM00622 LINC Skin Closure System (CM00622 LINC)