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    K Number
    K022708
    Device Name
    KLARITY
    Manufacturer
    LARSON PRODUCTS, INC.
    Date Cleared
    2002-11-12

    (90 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    LARSON PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Klarity thermoplastic is intended for use by licensed physicians and trained radiation therapy professionals for the external support and stabilization of patients undergoing radiation therapy treatment in a licensed clinical setting.
    Device Description
    Klarity™ is a "low temperature" Thermoplastic, which is pliant and moldable by hand when heated to a temperature of 155° F. (68° C.). Heating is best done by immersion in hot water. Klarity™ Thermoplastic is to be sold in sheets of thickness from 1.6mm to 3.2mm, in a variety of dimensions chosen to be compatible with similar devices already in use.
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