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510(k) Data Aggregation

    K Number
    K152166
    Device Name
    JSM Insulin Pen Needle
    Date Cleared
    2016-07-11

    (342 days)

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

    JEESUNG MEDICAL CO LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    JSM insulin pen needle is intended for use with pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.
    Device Description
    JSM insulin pen needle consists of a cap, needle, hub and paper. The cap and paper function to maintain the sterility of the needle. This device is single use and sterilized by EO gas. The hub can be connected with pen injector. After removing the paper, the needle can be screwed on to the pen. The needle cap protects the needle. This device has various gauge sizes (29G, 30G, 31G, 32G) and length (4mm, 5mm, 6mm, 10mm, 12mm) The color of needle cap per needle gauge is distinguished according to the standard given by our company.
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    K Number
    K152606
    Device Name
    Jeesung Safety Syringe and Single Use Needles
    Date Cleared
    2016-06-28

    (291 days)

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

    JEESUNG MEDICAL CO LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Jeesung safety syringe and single use needles is a sterile, single-use, disposable and non-reusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
    Device Description
    Jeesung Safety Syringe and Single Use Needles is an integrated needle and piston syringe with an anti-needle-stick mechanism. There is a swell on the top of inside barrel, which can be used to fix the hub of needle to the top of inside barrel. Four legs on the bottom of hub are caught on the swell part on the top of inside barrel when the hub is pulled. After using this syringe (such as injecting medicine into body etc.), the hub of needle is pulled back to the inside of the barrel. Because the four legs of hub is bound to the top of the plunger which has a smaller swell part than the top of inside barrel for being caught. Therefore, by pushing plunger until it makes a binding sound, the hub can follow with the plunger is broken off and the needle cannot be come out of the barrel. This renders the needle unusable and safe from accidental needle sticks. Jeesung Safety Syringe and Single Use Needles has syringe capacity of 3cc attached with 18-30 gauge and the length of the needle (8mm, 10mm, 13mm, 19mm, 25mm, 32mm, 38mm).
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