BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Embozene Color-Advanced Microspheres

    K Number: K180102 · Decision Apr 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    3
    Applicant Total
    58
    Review Days
    93

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    Basic Information

    Device Name
    Embozene Color-Advanced Microspheres
    K Number
    K180102
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5550
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific
    Date Received
    January 16, 2018
    Decision Date
    April 19, 2018
    Product Code
    NOY
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NOY Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia

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