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510(k) Data Aggregation

    K Number
    K050999
    Date Cleared
    2005-09-02

    (135 days)

    Product Code
    Regulation Number
    880.5860
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    YI XIN STERILE SYRINGE FOR SINGLE USE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    YI XIN Sterile Syringe for Single Use is a sterile, single-use, disposable and nonreusable syringe intended for injection of fluids into or withdraw fluids from the body.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about the acceptance criteria, device performance, study design, or specific results of a study as requested in the prompt. The letter confirms that the device, "YI XIN Sterile Syringe For Single Use," is substantially equivalent to predicate devices and can be marketed.

    Therefore, I cannot provide the requested information based on the given input.

    To answer your request, I would need a scientific report, clinical trial results, or a summary of performance testing for the device.

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