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

    SIGMA-BRILLEN (OR) MULTIPLE

    K Number: K930956 · Decision Oct 20, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    1086
    Registration Numbers
    1086
    Same Product Code
    197
    Applicant Total
    1
    Review Days
    239

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    Basic Information

    Device Name
    SIGMA-BRILLEN (OR) MULTIPLE
    K Number
    K930956
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5842
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sigma-Brillen
    Date Received
    February 23, 1993
    Decision Date
    October 20, 1993
    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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