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    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇦 Canada

    KHAN KINETIC TREATMENT (KKT-M2)

    K Number: K130666 · Decision Jan 23, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    31
    Applicant Total
    1
    Review Days
    317

    Basic Information

    Device Name
    KHAN KINETIC TREATMENT (KKT-M2)
    K Number
    K130666
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    OPTIMA HEALTH SOLUTIONS INTERNATIONAL CORPORATION
    Date Received
    March 12, 2013
    Decision Date
    January 23, 2014
    Product Code
    LXM
    Advisory Committee
    Unknown
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LXM Manipulator, Plunger-Like Joint

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