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

    STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS

    K Number: K854507 · Decision Feb 7, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    101
    Review Days
    87

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    Basic Information

    Device Name
    STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS
    K Number
    K854507
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4155
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Storz Instrument Co.
    Date Received
    November 12, 1985
    Decision Date
    February 7, 1986
    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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