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510(k) Data Aggregation

    K Number
    K212857
    Device Name
    Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use
    Date Cleared
    2023-05-09

    (608 days)

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

    Jiangsu Zhiyu Medical Instrument Co, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sterile Syringe for Single Use (with Needle) is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The Sterile Hypodermic Needle for Single Use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
    Device Description
    The Sterile Hypodermic Syringe is a sterile, single-use, polypropylene syringe that consists of the barrel, plunger, and stopper and is assembled with a hypodermic needle. The Sterile Hypodermic Needle is a single lumen needle made of austenitic steel, consisting of a protective cap, a needle seat and a needle tube connection.
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