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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    U&U Bowie-Dick Test Pack

    K Number: K143629 · Decision May 19, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    264
    Applicant Total
    10
    Review Days
    148

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    Basic Information

    Device Name
    U&U Bowie-Dick Test Pack
    K Number
    K143629
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    U&U Medical Technology Co, Ltd.
    Date Received
    December 22, 2014
    Decision Date
    May 19, 2015
    Product Code
    JOJ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOJ Indicator, Physical/Chemical Sterilization Process

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