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

    PROCEM

    K Number: K140644 · Decision Jun 19, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    98

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    Basic Information

    Device Name
    PROCEM
    K Number
    K140644
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ototronix, LLC
    Date Received
    March 13, 2014
    Decision Date
    June 19, 2014
    Product Code
    NEA
    Advisory Committee
    Dental
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NEA Cement, Ear, Nose And Throat

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