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

    DAILIES (NELFILCON A) ONE-DAY

    K Number: K992446 · Decision Aug 18, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    24
    Applicant Total
    1
    Review Days
    27

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    Basic Information

    Device Name
    DAILIES (NELFILCON A) ONE-DAY
    K Number
    K992446
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ciba Vision Johns Creek Mfg.
    Date Received
    July 22, 1999
    Decision Date
    August 18, 1999
    Product Code
    MVN
    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
    MVN Lens, Contact, (Disposable)

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