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510(k) Data Aggregation

    K Number
    K172095
    Device Name
    Autokeeper
    Manufacturer
    MedExel Co.,Ltd.
    Date Cleared
    2018-07-24

    (378 days)

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

    MedExel Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Autokeeper® Safety Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.
    Device Description
    Not Found
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