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510(k) Data Aggregation

    K Number
    K061007
    Device Name
    GOOD MEDY, DISPOSABLE THERMOMETER SHEATHS
    Manufacturer
    GOOD MEDY ENTERPRISE LTD.
    Date Cleared
    2006-06-14

    (64 days)

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

    GOOD MEDY ENTERPRISE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The devices are intended for use as a barrier that is used as an accessory to oral or rectal for digital thermometers. These sheaths are non-sterile and are intended for single patient use only.
    Device Description
    The disposable thermometer sheaths are plastic coverings used for either oral or rectal for digital thermometer. The products and its packaging are non-sterile and latex-free.
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