BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DOHLMAN DOANE KERATOPROTHESIS

    K Number: K915062 · Decision Jan 21, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    74

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    Basic Information

    Device Name
    DOHLMAN DOANE KERATOPROTHESIS
    K Number
    K915062
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3400
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mackeen Consultants, Ltd.
    Date Received
    November 8, 1991
    Decision Date
    January 21, 1992
    Product Code
    HQM
    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
    HQM Keratoprosthesis, Permanent Implant

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