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510(k) Data Aggregation

    K Number
    K192464
    Device Name
    Injection Pen Needle
    Date Cleared
    2020-08-25

    (351 days)

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

    Gangan Medical Technology Jiangsu Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Injection Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.
    Device Description
    The Injection Pen Needle is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. It consists of a seal, needle hub, needle tube, needle sheath and primary container. The Injection Pen Needle is offered in the following sizes: Model(s): 0.30x6mm/30G, 0.30x8mm/30G, 0.25x6mm/31G, 0.25x8mm/31G, 0.23x4mm/32G. It is a single-use disposable device that is provided sterile and has a shelf life of 3 years. The needle hub is connects to the pen injector and the needle tube punctures the sealed medicine container. The medicine solution is pushed out through the needle tube by the injection mechanism of the pen injector. The needle tube is a stainless steel needle tube with lubricant coating on the surface and a beveled tip. The seal (medical glue-coated dialysis paper) and the primary container (medical polypropylene) constitute the sterile barrier system of the product.
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