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

    FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES

    K Number: K003586 · Decision Feb 8, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    24
    Applicant Total
    2
    Review Days
    80

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    Basic Information

    Device Name
    FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES
    K Number
    K003586
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ciba-Geigy Corp.
    Date Received
    November 20, 2000
    Decision Date
    February 8, 2001
    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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    Other Clearances by Ciba-Geigy Corp.

    K Number Device Name
    K833922 BRETHANCER, DRUG DELIVERY SYS-INHAL