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

    MONTGOMERY THYROPLASTY IMPLANT SYSTEM

    K Number: K972317 · Decision Sep 18, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    16
    Applicant Total
    33
    Review Days
    90

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    Basic Information

    Device Name
    MONTGOMERY THYROPLASTY IMPLANT SYSTEM
    K Number
    K972317
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Medical Products, Inc.
    Date Received
    June 20, 1997
    Decision Date
    September 18, 1997
    Product Code
    MIX
    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
    MIX System, Vocal Cord Medialization

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