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510(k) Data Aggregation

    K Number
    K221308
    Device Name
    Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle
    Date Cleared
    2022-10-17

    (165 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jiangxi Maidikang Medical Devices Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential of syringe reuse. The Disposable Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
    Device Description
    The proposed Syringes include Disposable Syringe with permanently attached needle and a Safety Syringe with permanently attached needle. The Disposable Syringe with permanently attached needle have one kind of product configuration, and the Safety Syringe with permanently attached needle has two kinds of product configurations. The proposed syringes are available in different combination of syringe volumes and/or needle sizes, and the syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterile in packaging to maintain the sterility of the device during the shelf life of three years.
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