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

    OTO-CEM

    K Number: K011338 · Decision Sep 13, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    134

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    Basic Information

    Device Name
    OTO-CEM
    K Number
    K011338
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ototech, Inc.
    Date Received
    May 2, 2001
    Decision Date
    September 13, 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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