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

    IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES

    K Number: K861545 · Decision May 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    234
    Registration Numbers
    235
    Same Product Code
    76
    Applicant Total
    2
    Review Days
    34

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    Basic Information

    Device Name
    IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES
    K Number
    K861545
    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 24, 1986
    Decision Date
    May 28, 1986
    Product Code
    HMX
    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
    HMX Cannula, Ophthalmic

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    Other Clearances by Rophae Lens Co., Inc.

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