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510(k) Data Aggregation

    K Number
    K971875
    Device Name
    OPTIM-EYES 450
    Date Cleared
    1997-06-13

    (24 days)

    Product Code
    Regulation Number
    886.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    TAYLOR/FOX ENTERPRISES, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Optim-Eyes 450 sunglasses are worn by persons to protect the eyes from bright sunlight, including 100% and UVB, and blue light up to 450 nanometers.
    Device Description
    The Optim-Eyes 450 are non-prescription sunglasses constructed of commonly used materials for sunglass and spectacle frames and lenses.
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