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

    ROSS-EMERSON PUMP, MODEL 55-R

    K Number: K811779 · Decision Jul 13, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    13
    Applicant Total
    25
    Review Days
    20

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    Basic Information

    Device Name
    ROSS-EMERSON PUMP, MODEL 55-R
    K Number
    K811779
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4370
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    J. H. Emerson Co.
    Date Received
    June 23, 1981
    Decision Date
    July 13, 1981
    Product Code
    KQT
    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
    KQT Evacuator, Gastro-Urology

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