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510(k) Data Aggregation

    K Number
    K113199
    Device Name
    KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT
    Manufacturer
    KEVO MEDICAL SUPPLIES
    Date Cleared
    2012-07-30

    (273 days)

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

    KEVO MEDICAL SUPPLIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Kevo NPWT- αHemo30 Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4 Wound Vacuum System (K082676) to deliver negative pressure wound therapy to the wound. Kevo NPWT- αHemo30 Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris. Kevo NPWT - αHemo30 Foam Dressing Kit is appropriate for use on the following wounds: - Pressure Ulcers . - Diabetic/Neuropathic Ulcers . - Venous Insufficiency Ulcers . - Traumatic Wounds . - Post-Operative and Dehisced Surgical Wounds . - Skin Flaps and Grafts . Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
    Device Description
    The Kevo NPWT- α.Hemo30 Foam Dressing Kit is manufactured using a reticulated flexible polyether and polyurethane hydrophobic foam material. The single-use dressing is housed in a Tyvek/Mylar Peel Pouch which is sterilized using EtO. The Kevo NPWT- αHemo30 Foam Dressing Kit is available in three sizes; 1) small, 2) medium and 3) large: Small: 100mm x 80mm x 30mm Medium: 125mm x 190mm x 30mm Large: 150mm x 250mm x 30mm
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