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

    VISITEC SCLERAL PLUG

    K Number: K945114 · Decision Feb 23, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    49
    Review Days
    128

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    Basic Information

    Device Name
    VISITEC SCLERAL PLUG
    K Number
    K945114
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4155
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Visitec Co.
    Date Received
    October 18, 1994
    Decision Date
    February 23, 1995
    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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