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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    EMG SUCTION UNIT

    K Number: K112421 · Decision Sep 1, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    76
    Applicant Total
    11
    Review Days
    9

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    Basic Information

    Device Name
    EMG SUCTION UNIT
    K Number
    K112421
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Emg Technology Co., Ltd.
    Date Received
    August 23, 2011
    Decision Date
    September 1, 2011
    Product Code
    JCX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered

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