BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SPECTACLE SUN GLASSES (NON PRESCRIPTION)

    K Number: K934081 · Decision Oct 18, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    1390
    Registration Numbers
    1390
    Same Product Code
    645
    Applicant Total
    2
    Review Days
    59

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    Basic Information

    Device Name
    SPECTACLE SUN GLASSES (NON PRESCRIPTION)
    K Number
    K934081
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    South American Optical, Inc.
    Date Received
    August 20, 1993
    Decision Date
    October 18, 1993
    Product Code
    HQY
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HQY Sunglasses (Non-Prescription Including Photosensitive)

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