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

    EMPTY SOLUTION TRANSFER CONTAINER 1,500 ML

    K Number: K861494 · Decision Aug 18, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    1
    Review Days
    118

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    Basic Information

    Device Name
    EMPTY SOLUTION TRANSFER CONTAINER 1,500 ML
    K Number
    K861494
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Polymer Technologies
    Date Received
    April 22, 1986
    Decision Date
    August 18, 1986
    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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