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

    KLAAS IOL LENSFOLDER

    K Number: K930628 · Decision Feb 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    38
    Applicant Total
    2
    Review Days
    729

    Basic Information

    Device Name
    KLAAS IOL LENSFOLDER
    K Number
    K930628
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    BOVA INTL.
    Date Received
    February 8, 1993
    Decision Date
    February 7, 1995
    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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