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

    KRATZ NOVA SERT(TM)

    K Number: K883489 · Decision Oct 25, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    38
    Applicant Total
    2
    Review Days
    70

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    Basic Information

    Device Name
    KRATZ NOVA SERT(TM)
    K Number
    K883489
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Coopervision-Cilco
    Date Received
    August 16, 1988
    Decision Date
    October 25, 1988
    Product Code
    KYB
    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
    KYB Lens, Guide, Intraocular

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