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

    EFFNER-EYE CAUTERY WITH BATTERY HANDLE

    K Number: K844775 · Decision Aug 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    11
    Applicant Total
    14
    Review Days
    245

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    Basic Information

    Device Name
    EFFNER-EYE CAUTERY WITH BATTERY HANDLE
    K Number
    K844775
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4115
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Mecron Medical Products, Inc.
    Date Received
    December 10, 1984
    Decision Date
    August 12, 1985
    Product Code
    HQO
    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
    HQO Unit, Cautery, Thermal, Ac-Powered

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