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

    ADLER DISPOSABLE BIPOLAR CORD

    K Number: K900913 · Decision Apr 4, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    11
    Applicant Total
    8
    Review Days
    36

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    Basic Information

    Device Name
    ADLER DISPOSABLE BIPOLAR CORD
    K Number
    K900913
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4115
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Adler Instrument Co.
    Date Received
    February 27, 1990
    Decision Date
    April 4, 1990
    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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