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

    MODIFICATION TO VF GEL PLUS

    K Number: K080956 · Decision Apr 25, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    16
    Applicant Total
    17
    Review Days
    22

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    Basic Information

    Device Name
    MODIFICATION TO VF GEL PLUS
    K Number
    K080956
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coapt Systems, Inc.
    Date Received
    April 3, 2008
    Decision Date
    April 25, 2008
    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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