LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974511
    Device Name
    SUNGLASSES
    Manufacturer
    SUN WORLD INTL., INC.
    Date Cleared
    1998-01-12

    (42 days)

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

    SUN WORLD INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
    Ask a Question

    Page 1 of 1