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

    ATTIC DEFECT PLATE

    K Number: K921433 · Decision Mar 18, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    0
    Applicant Total
    87
    Review Days
    358

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    Basic Information

    Device Name
    ATTIC DEFECT PLATE
    K Number
    K921433
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3430
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Richards, Inc.
    Date Received
    March 25, 1992
    Decision Date
    March 18, 1993
    Product Code
    ETC
    Advisory Committee
    Ear, Nose, Throat
    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
    ETC Mold, Middle-Ear

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