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510(k) Data Aggregation

    K Number
    K140022
    Device Name
    NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT
    Manufacturer
    CORK MEDICAL PRODUCTS LLC
    Date Cleared
    2014-10-24

    (294 days)

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

    CORK MEDICAL PRODUCTS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cork Medical Products Nisus Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material, and tissue debris.
    Device Description
    Cork Medical Products has developed a negative pressure wound therapy system. The Cork Medical Products Nisus Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material, and tissue debris. The components included within the Cork NPWT System are: - Nisus Negative Pressure Wound Therapy Pump - Nisus NPWT Canister 250-mL - Nisus Pump Battery Charger - Cork Medical Products NPWT Wound Dressing Kit – Medium - Cork Medical Products NPWT Wound Dressing Kit - Large
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