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

    SILASTIC VOICE PROSTHESIS

    K Number: K812864 · Decision Nov 24, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    39
    Applicant Total
    31
    Review Days
    42

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    Basic Information

    Device Name
    SILASTIC VOICE PROSTHESIS
    K Number
    K812864
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3730
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Dow Corning Corp. Healthcare Industries Materials
    Date Received
    October 13, 1981
    Decision Date
    November 24, 1981
    Product Code
    EWL
    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
    EWL Prosthesis, Laryngeal (Taub)

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