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510(k) Data Aggregation

    K Number
    K040105
    Device Name
    YUE PFONG SAFETY SYRINGE (3ML)
    Date Cleared
    2004-04-07

    (78 days)

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

    YUE PFONG INTERNATIONAL INDUSTRIAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The YUE PFONG® Safety Syringe (3ml) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and manual retractable safety syringe which is intended for injection of medical fluids into the body.
    Device Description
    The YUE PFONG® Safety Syringe (3ml) is sterile, single-use, disposable , Non-reusable, Manual , Retractable, 3ml Piston Syringe, provided with needle attached in place., which is used for injection of fluids into the body. (Needle Spec. including 1'/2" or shorter, 18-28 gauge). The YUE PFONG® Safety Syringe (3ml) consist of the following major components. 1 Plunger , 2 Barrel , 3 Piston, @ adaptor , $ O- Ring , 6 Needle & Needle Hub, 7 Needle Sheath.
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