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

    MPS ACACIA PAIN KIT

    K Number: K003476 · Decision Jan 12, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    87
    Applicant Total
    7
    Review Days
    64

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    Basic Information

    Device Name
    MPS ACACIA PAIN KIT
    K Number
    K003476
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mps Acacia
    Date Received
    November 9, 2000
    Decision Date
    January 12, 2001
    Product Code
    MEB
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MEB Pump, Infusion, Elastomeric

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    Other Clearances by Mps Acacia

    K Number Device Name
    K090809 MPS ACACIA POWER INJECTABLE INFUSION SET
    K080328 MPS ACACIA ENTERAL FEEDING TUBE
    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