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

    STRATUM ESU

    K Number: K874719 · Decision Feb 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    35
    Applicant Total
    6
    Review Days
    91

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    Basic Information

    Device Name
    STRATUM ESU
    K Number
    K874719
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Alternative Design Systems, Inc.
    Date Received
    November 17, 1987
    Decision Date
    February 16, 1988
    Product Code
    JOS
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOS Electrode, Electrosurgical

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