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

    MANDIBLE MANIPULATOR

    K Number: K884308 · Decision Mar 31, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    71
    Applicant Total
    7
    Review Days
    169

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    Basic Information

    Device Name
    MANDIBLE MANIPULATOR
    K Number
    K884308
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Leonard Medical, Inc.
    Date Received
    October 13, 1988
    Decision Date
    March 31, 1989
    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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