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

    PRESTIGE FRAMES

    K Number: K940201 · Decision Feb 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    1189
    Registration Numbers
    1190
    Same Product Code
    197
    Applicant Total
    1
    Review Days
    40

    Basic Information

    Device Name
    PRESTIGE FRAMES
    K Number
    K940201
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5842
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    EYE THINK EYEWEAR
    Date Received
    January 13, 1994
    Decision Date
    February 22, 1994
    Product Code
    HQZ
    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
    HQZ Frame, Spectacle

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