BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CUI PREMAXILLARY IMPLANT

    K Number: K903328 · Decision Sep 10, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    41
    Applicant Total
    7
    Review Days
    47

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    Basic Information

    Device Name
    CUI PREMAXILLARY IMPLANT
    K Number
    K903328
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3680
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Cui Corp.
    Date Received
    July 25, 1990
    Decision Date
    September 10, 1990
    Product Code
    FZE
    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
    FZE Prosthesis, Nose, Internal

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    Other Clearances by Cui Corp.

    K Number Device Name
    K913140 SILICONE GEL SHEETING
    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