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510(k) Data Aggregation

    K Number
    K974414
    Device Name
    MULTI
    Manufacturer
    MORNING CALM CORP.
    Date Cleared
    1997-12-08

    (14 days)

    Product Code
    HQY
    Regulation Number
    886.5850
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Non-prescription sunglasses are for general use to protect eyes from strong sunlight

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter from the FDA for "Sunglasses." This type of document is a regulatory approval, not a scientific study describing device performance and acceptance criteria.

    Therefore, none of the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth, etc.) can be extracted from the provided text. The letter simply states that the device (sunglasses) is substantially equivalent to legally marketed predicate devices and can proceed to market.

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