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510(k) Data Aggregation

    K Number
    K203211
    Device Name
    Insulin syringe with integrated needle DL
    Date Cleared
    2023-02-09

    (832 days)

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

    DLP Medical Products, Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Disposable syringe for insulin administration, for the patient with diabetes.
    Device Description
    Insulin syringe with integrated extra thin stainless-steel needle and dead space less than 0.005 ml, made of medical grade plastic, sterile, disposable, pyrogen free and non-toxic. Sterilized by ethylene oxide. The product is composed of the following parts: Cylinder or barrel, Piston, Plunger, Needle, Needle cover or protector.
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