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510(k) Data Aggregation

    K Number
    K971707
    Device Name
    SUNGLASSES (NON-PRESCRIPTION)
    Manufacturer
    NIKO SUNGLASSES CORP.
    Date Cleared
    1997-06-13

    (38 days)

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

    NIKO SUNGLASSES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.
    Device Description
    Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.
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