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

    TWBM Pump

    K Number: K180115 · Decision Jul 24, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    76
    Applicant Total
    2
    Review Days
    189

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    Basic Information

    Device Name
    TWBM Pump
    K Number
    K180115
    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
    Taiwan Biomaterial Co., Ltd.
    Date Received
    January 16, 2018
    Decision Date
    July 24, 2018
    Product Code
    JCX
    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
    JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered

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    Other Clearances by Taiwan Biomaterial Co., Ltd.

    K Number Device Name
    K190105 ZOOM Aspiration Pump