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

    SERENOCEM, MODEL BC 010

    K Number: K003567 · Decision Feb 12, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    84

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    Basic Information

    Device Name
    SERENOCEM, MODEL BC 010
    K Number
    K003567
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Corinthian Medical , Ltd.
    Date Received
    November 20, 2000
    Decision Date
    February 12, 2001
    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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