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

    DUCKBILL VOICE PROSTHESIS & TRACHEO

    K Number: K832967 · Decision Dec 23, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    39
    Applicant Total
    31
    Review Days
    113

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    Basic Information

    Device Name
    DUCKBILL VOICE PROSTHESIS & TRACHEO
    K Number
    K832967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3730
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    American V. Mueller
    Date Received
    September 1, 1983
    Decision Date
    December 23, 1983
    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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    K854568 V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP
    K854049 HEYER-SCHULTE SYRINGO PERITONEAL SHUNT
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