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510(k) Data Aggregation

    K Number
    K013715
    Device Name
    RE-USABLE STERILIZATION POUCH / BAG
    Date Cleared
    2002-04-01

    (144 days)

    Product Code
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUALITY PRODUCTS OF MONTANA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a re-usable sterilization pouch designed to The device the sterilization process and allow a simple method of packaging devices to maintain sterility. Acceptable method of sterilization is moist heat sterilization where the temperature is below 137℃ (273°F). The pouch may be re-used up to 30 times in dental practices and approved for 90 days storage.
    Device Description
    The device is a re-usable sterilization pouch designed to The device the sterilization process and allow a simple method of packaging devices to maintain sterility.
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