BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SILICONE GEL SHEETING

    K Number: K913140 · Decision Sep 30, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    190
    Registration Numbers
    190
    Same Product Code
    80
    Applicant Total
    7
    Review Days
    76

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    Basic Information

    Device Name
    SILICONE GEL SHEETING
    K Number
    K913140
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4025
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cui Corp.
    Date Received
    July 16, 1991
    Decision Date
    September 30, 1991
    Product Code
    MDA
    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
    MDA Elastomer, Silicone, For Scar Management

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    Other Clearances by Cui Corp.

    K Number Device Name
    K904348 CUI FEATHERED SILICONE MALAR
    K904350 CUI DORSAL COLUMELLA PROSTHESIS
    K904349 CUI CURVILINEAR SILICONE CHIN
    K903329 CUI ANATOMICAL SILICONE MALAR
    K903327 CUI ARTICULATED SILICONE CHIN
    K903328 CUI PREMAXILLARY IMPLANT