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510(k) Data Aggregation

    K Number
    K124037
    Device Name
    JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE
    Date Cleared
    2013-09-12

    (258 days)

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

    JUNG RIM MEDICAL INDUSTRIAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Jung Rim single use hypodermic syringe with Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
    Device Description
    The Single use hypodermic Syringe with Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The product consists of a Barrel, Piston, Gasket, Needle Needle cap. The Single use hypodermic Syringe with Needle are offered various sizes (Luer slip (1.3.5,10,20,30,50 (ml)), and Needle size (16G, 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G) Proposed syringes will be provided along with a proposed needle in one single package. The combinations of sizes are various upon the request of the users. These are sterile (Eo gas sterilization). The devices are disposable, single use devices.
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