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

    KHAN KINETIC TREATMENT DEVICE (KKT-M1)

    K Number: K060043 · Decision Mar 23, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    31
    Applicant Total
    1
    Review Days
    76

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    Basic Information

    Device Name
    KHAN KINETIC TREATMENT DEVICE (KKT-M1)
    K Number
    K060043
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Optima Health Solutions International, Inc.
    Date Received
    January 6, 2006
    Decision Date
    March 23, 2006
    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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