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

    ENTROSET-SW

    K Number: K871003 · Decision Jun 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    2
    Review Days
    84

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    Basic Information

    Device Name
    ENTROSET-SW
    K Number
    K871003
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    White River (Tm)
    Date Received
    March 12, 1987
    Decision Date
    June 4, 1987
    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 White River (Tm)

    K Number Device Name
    K925738 WHITE RIVER MANUAL BREAST PUMP