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

    ECKHARDT TEMPORARY KERATOPROSTHESIS

    K Number: K902491 · Decision Jun 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    10
    Review Days
    21

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    Basic Information

    Device Name
    ECKHARDT TEMPORARY KERATOPROSTHESIS
    K Number
    K902491
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3400
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Dutch Ophthalmic USA, Inc.
    Date Received
    June 5, 1990
    Decision Date
    June 26, 1990
    Product Code
    MLP
    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
    MLP Keratoprosthesis, Temporary Implant, Surgical Use

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