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510(k) Data Aggregation

    K Number
    K032301
    Device Name
    NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900
    Manufacturer
    NEOGEN TECHNOLOGIES, INC
    Date Cleared
    2003-08-21

    (27 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOGEN TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeoGen One device is indicated for patients who would benefit from a suction device, particularly as the use of that device may promote wound healing. This includes patients who would benefit from vacuum-assisted drainage and removal of infectious material or other fluids from wounds under influence of continuous and/or alternating vacuum pressure. This device is restricted to sale by, or on the order of, a physician or licensed practitioner.
    Device Description
    NeoGen One. Closed Wound Drain System Part Number: NG9900
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