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510(k) Data Aggregation

    K Number
    K143070
    Device Name
    Disposable Safety Self-destructive Syringes, 5 ML
    Date Cleared
    2015-07-07

    (253 days)

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

    Jiangsu Yile Medical Article Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Safety Self-destructive is used to inject fluids into, or withdraw fluids from the body. In addition, it is designed to aid in the prevention of needle stick injuries.
    Device Description
    The JIANGSU YILE MEDICAL ARTICAL C0., LTD Disposable Safety Self-destructive Syringes, 5MLs are single lumen hypodermic needles with a safety mechanism to prevent needle stick after the usage. The Disposable Safety Self-destructive Syringe is used to inject fluids into, or withdraw fluids from the body. In addition, it is designed to aid in the prevention of needle stick injuries. The syringes are made of a protector, needle, up connector, 0-ring seal, down connector, barrel, piston and plunger. The syringe and body are constructed of Polypropylene (PP). The piston and 0-ring seal are made of natural rubber. Lumens are constructed of 304 Stainless Steel.
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