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    K Number
    K102508
    Device Name
    YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02
    Manufacturer
    YU LONG SHENG TECHNOLOGY CO., LTD
    Date Cleared
    2011-01-10

    (131 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    YU LONG SHENG TECHNOLOGY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    YLS-01 is intended for use as a barrier that is used as an accessory to oral or rectal for digital thermometers. This sheath is non-sterile and is intended for single patient use only.
    Device Description
    The Yu Long Sheng Disposable Thermometer Sheath(model YLS-01) is a plastic covering used for oral/rectal digital thermometer. This device is not made with natural rubber latex
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