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

    ROPHAE DIAMOND KNIFE

    K Number: K861491 · Decision May 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    206
    Registration Numbers
    207
    Same Product Code
    53
    Applicant Total
    2
    Review Days
    36

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    Basic Information

    Device Name
    ROPHAE DIAMOND KNIFE
    K Number
    K861491
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Rophae Lens Co., Inc.
    Date Received
    April 22, 1986
    Decision Date
    May 28, 1986
    Product Code
    HNN
    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
    HNN Knife, Ophthalmic

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    Other Clearances by Rophae Lens Co., Inc.

    K Number Device Name
    K861545 IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES