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510(k) Data Aggregation

    K Number
    K974861
    Device Name
    NON-PRESCRIPTION SUNGLASSES
    Manufacturer
    WENZHOU HINDAR OPTICAL CO., LTD.
    Date Cleared
    1998-01-27

    (29 days)

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

    WENZHOU HINDAR OPTICAL CO., LTD.

    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 photosenstitzed 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 photosenstitzed 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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