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510(k) Data Aggregation

    K Number
    K974852
    Device Name
    NON-PRESCRIPTION SUNGLASSES
    Manufacturer
    CHIA HUI SPECTACLES MFG. CORP.
    Date Cleared
    1998-01-30

    (32 days)

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

    CHIA HUI SPECTACLES MFG. CORP.

    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
    Not Found
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