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

    ARTIFICIAL SCLERAL SHELL

    K Number: K904961 · Decision Aug 30, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    298

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    Basic Information

    Device Name
    ARTIFICIAL SCLERAL SHELL
    K Number
    K904961
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3800
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Midwest Eye Laboratories, Inc.
    Date Received
    November 5, 1990
    Decision Date
    August 30, 1991
    Product Code
    HQT
    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
    HQT Shell, Scleral

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    Other Clearances by Midwest Eye Laboratories, Inc.

    K Number Device Name
    K904962 EYE ARTIFICIAL CUSTOM