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

    COMPLETE BLINK-N-CLEAN LENS DROPS

    K Number: K040839 · Decision Oct 19, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    32
    Applicant Total
    8
    Review Days
    202

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    Basic Information

    Device Name
    COMPLETE BLINK-N-CLEAN LENS DROPS
    K Number
    K040839
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    886.5918
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Medical Optics, Inc.
    Date Received
    March 31, 2004
    Decision Date
    October 19, 2004
    Product Code
    MRC
    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
    MRC Products, Contact Lens Care, Rigid Gas Permeable

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