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

    EXAMIX DISPENSER

    K Number: K880849 · Decision May 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    71
    Applicant Total
    23
    Review Days
    71

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    Basic Information

    Device Name
    EXAMIX DISPENSER
    K Number
    K880849
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    G-C Intl. Corp.
    Date Received
    March 1, 1988
    Decision Date
    May 11, 1988
    Product Code
    EKJ
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EKJ Burnisher, Operative

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