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

    OPTICAL FRAMES

    K Number: K945770 · Decision Dec 15, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    1086
    Registration Numbers
    1086
    Same Product Code
    197
    Applicant Total
    1
    Review Days
    43

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    Basic Information

    Device Name
    OPTICAL FRAMES
    K Number
    K945770
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5842
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ramada Optics, Inc.
    Date Received
    November 2, 1994
    Decision Date
    December 15, 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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