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510(k) Data Aggregation

    K Number
    K210914
    Device Name
    Sterile Syringe for Single Use
    Date Cleared
    2021-12-17

    (263 days)

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

    Jiangsu Suyun Medical Material Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sterile Syringe for Single Use is intended for use by health care professionals for general purpose aspiration and injection of fluids.
    Device Description
    The Syringe with needle is intended for manual and single use only. It consists of six components 1) Barrel (luer lock or luer slip) 2) Plunger 3) Piston 4) Needle Tube 5) Protective Cap and 6) Needle Hub. The proposed device is available in various combination of syringe volume, connector type (luer lock or luer slip), connector location (central type or eccentric type) and needle size. The Syringe without needle is intended for manual and single use only. It consists of three components 1) Barrel (luer lock or luer slip) 2) Plunger and 3) Piston. The proposed syringe is available in various combination of syringe volume, connector type (luer lock or luer slip), and connector location (central type or eccentric type). The proposed device is sterilized by Ethylene Oxide to achieve a SAL of 106 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.
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