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510(k) Data Aggregation

    K Number
    K121637
    Device Name
    AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE
    Manufacturer
    SUNWELL BIOTECH CO., LTD
    Date Cleared
    2012-10-25

    (143 days)

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

    SUNWELL BIOTECH CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Auto-Disable Sterile Safety Syringe for Single Use ,5ml, is used to inject fluids into, or withdraw fluids from the body. In addition, the retractable needle of the syringe goes into the barrel after use. It is designed to aid in the prevention of needle stick injuries.
    Device Description
    The Auto-Disable Sterile Safety Syringe for Single Use is used to inject fluids into, or withdraw fluids from the body. In addition, the retractable needle of the syringe goes into the barrel after use. It is designed to aid in the prevention of needle stick injuries. The retractable type of piston syringe is a plastic disposable anti-needle stick syringe made of the below components: Cap, Needle, Needle house, Hub, Barrel, Gasket, Plunger.
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