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510(k) Data Aggregation

    K Number
    K213013
    Device Name
    Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
    Manufacturer
    Jeil Tech Co., Ltd.
    Date Cleared
    2022-09-19

    (364 days)

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

    Jeil Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    STERILE SINGLE USE LDV SYRINGE/CHOICARE STERILE SINGLE USE LDV SYRINGE is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
    Device Description
    A Disposable Syringe with Needle is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a hypodermic single lumen needle which is permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. This is a single-use device. This product is packed by sterile paper and sterilized by E.O gas.
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