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    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    TRAUS SUS10

    K Number: K151171 · Decision Sep 1, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    48
    Applicant Total
    18
    Review Days
    123

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    Basic Information

    Device Name
    TRAUS SUS10
    K Number
    K151171
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4120
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Saeshin Precision Co., Ltd.
    Date Received
    May 1, 2015
    Decision Date
    September 1, 2015
    Product Code
    DZI
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DZI Drill, Bone, Powered

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