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

    MPS ACACIA ENTERAL FEEDING TUBE

    K Number: K080328 · Decision May 14, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    7
    Review Days
    97

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    Basic Information

    Device Name
    MPS ACACIA ENTERAL FEEDING TUBE
    K Number
    K080328
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mps Acacia
    Date Received
    February 7, 2008
    Decision Date
    May 14, 2008
    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 Mps Acacia

    K Number Device Name
    K090809 MPS ACACIA POWER INJECTABLE INFUSION SET
    K052946 MPS ACACIA NERVE BLOCK NEEDLE
    K052451 MPS ACACIA MEDFLO ELASTOMERIC PUMP
    K032934 MPS ACACIA SAFEGUARD HUBER DEVICE
    K011117 MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS
    K003476 MPS ACACIA PAIN KIT