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

    BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL

    K Number: K963512 · Decision Jul 31, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    117
    Applicant Total
    12
    Review Days
    335

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    Basic Information

    Device Name
    BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL
    K Number
    K963512
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Benz Research and Development Corp.
    Date Received
    August 30, 1996
    Decision Date
    July 31, 1997
    Product Code
    HQD
    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
    HQD Lens, Contact (Other Material) - Daily

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