BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    SurgiCube

    K Number: K163455 · Decision Sep 28, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    293

    Basic Information

    Device Name
    SurgiCube
    K Number
    K163455
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5070
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SURGICUBE INTERNATIONAL B.V.
    Date Received
    December 9, 2016
    Decision Date
    September 28, 2017
    Product Code
    ORC
    Advisory Committee
    General, Plastic Surgery
    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
    ORC Air Filter Portable Apparatus

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