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

    ESOPHAGEAL TUBE

    K Number: K841349 · Decision Jul 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    6
    Review Days
    112

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    Basic Information

    Device Name
    ESOPHAGEAL TUBE
    K Number
    K841349
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    E. Benson Hood Laboratories, Inc.
    Date Received
    April 2, 1984
    Decision Date
    July 23, 1984
    Product Code
    KNT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by E. Benson Hood Laboratories, Inc.

    K Number Device Name
    K983878 CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE
    K841350 SALIVARY BYPASS TUBE
    K841266 MONTGOMERY TRACHEAL T-TUBE
    K841347 LARYNGEAL STENT
    K841348 UMBRELLA KEEL