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510(k) Data Aggregation

    K Number
    K231856
    Device Name
    TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
    Manufacturer
    MedExel Co., Ltd.
    Date Cleared
    2024-03-15

    (266 days)

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

    MedExel Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TopFine® LDS (Low Dead Space) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.
    Device Description
    The TopFine® LDS (Low Dead Space) Syringe 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 a permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. It is made of plastic and silicone materials that allows for smooth plunger movement, and is manually operated. This is a single-use device. This product is packed by sterile paper and sterilized by Ethylene Oxide gas. The proposed device has 2 models depending on the diameter of the needle.
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    K Number
    K152410
    Device Name
    Top Fine Pen Needle
    Manufacturer
    MEDEXEL CO., LTD.
    Date Cleared
    2016-02-02

    (160 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDEXEL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Top Fine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.
    Device Description
    Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm). Top Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic. Top Fine® Pen Needle assembly consists of hub, needle cap, sterile cap and sterile paper.
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