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

    SITE-MALIS BIPOLAR COAGULATOR MODULE

    K Number: K852075 · Decision Aug 20, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    11
    Applicant Total
    27
    Review Days
    99

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    Basic Information

    Device Name
    SITE-MALIS BIPOLAR COAGULATOR MODULE
    K Number
    K852075
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4115
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Valley Forge Scientific Corp.
    Date Received
    May 13, 1985
    Decision Date
    August 20, 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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