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510(k) Data Aggregation

    K Number
    K160575
    Device Name
    CareSens Pen Needle, Softip Pen Needle
    Manufacturer
    Date Cleared
    2016-09-07

    (190 days)

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

    YIDOBIO INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CareSens Pen Needle and Softip Pen Needle are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.
    Device Description
    CareSens Pen Needle and Softip Pen Needle are sterile, non-pyrogenic, single-use injection needles intended for use with injection pens. This needle is a device for subcutaneous injection of medicines such as insulin and exenatide used with pen injectors for subcutaneous injection. CareSens Pen Needle and Softip Pen Needle are the same product in exception to the brand name.
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