BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    UNFOLDER Vitan Inserter

    K Number: K191949 · Decision Sep 13, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    62
    Applicant Total
    4
    Review Days
    53

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    Basic Information

    Device Name
    UNFOLDER Vitan Inserter
    K Number
    K191949
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    886.4300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Surgical Vision, Inc.
    Date Received
    July 22, 2019
    Decision Date
    September 13, 2019
    Product Code
    MSS
    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
    MSS Folders And Injectors, Intraocular Lens (Iol)

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