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

    Silk Voice (SMI-04)

    K Number: K240919 · Decision May 3, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    30

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    Basic Information

    Device Name
    Silk Voice (SMI-04)
    K Number
    K240919
    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
    Sofregen Medical
    Date Received
    April 3, 2024
    Decision Date
    May 3, 2024
    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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