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

    DISPOSABLE SCLERAL GLOBE PLUG

    K Number: K840693 · Decision May 22, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    12
    Review Days
    96

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    Basic Information

    Device Name
    DISPOSABLE SCLERAL GLOBE PLUG
    K Number
    K840693
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4155
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Innovative Surgical Products, Inc.
    Date Received
    February 16, 1984
    Decision Date
    May 22, 1984
    Product Code
    LXP
    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
    LXP Plug, Scleral

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