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510(k) Data Aggregation

    K Number
    K020296
    Device Name
    ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057
    Manufacturer
    APOTHECARY PRODUCTS, INC.
    Date Cleared
    2002-06-25

    (148 days)

    Product Code
    EWD
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057

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

    Adult Silicone Ear Plugs are used for protection from noise. This device is for adult use only.

    Device Description

    Adult Silicone Ear Plug

    AI/ML Overview

    The provided document is a 510(k) clearance letter for a medical device (Adult Silicone Ear Plugs). It does NOT contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment relevant to AI/algorithm performance.

    Therefore, I cannot fulfill the request using the given input. The document is solely a regulatory approval for marketing the device, confirming its substantial equivalence to a predicate device.

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