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

    ARGYLE POLYURETHANE SALEM SUMP TUBE

    K Number: K910479 · Decision Apr 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    12
    Applicant Total
    191
    Review Days
    72

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    Basic Information

    Device Name
    ARGYLE POLYURETHANE SALEM SUMP TUBE
    K Number
    K910479
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Sherwood Medical Co.
    Date Received
    February 6, 1991
    Decision Date
    April 19, 1991
    Product Code
    BSS
    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
    BSS Tube, Nasogastric

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