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510(k) Data Aggregation

    K Number
    K013502
    Device Name
    SIMPLICITY CLASSIC WING QD INFUSION SET
    Manufacturer
    STERLING MEDIVATIONS, INC.
    Date Cleared
    2001-12-03

    (42 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the Simplicity Classic Wing QD Infusion Set is to provide a means to for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for an infusion set. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment for a medical device's AI component. Therefore, I cannot fulfill your request based on the given input.

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