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510(k) Data Aggregation

    K Number
    K122490
    Device Name
    KULAVAC
    Manufacturer
    Date Cleared
    2013-11-13

    (455 days)

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

    CGBIO CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    KulaVAC Foam Dressing Kit is intended to be used in conjunction with suction devices to deliver negative pressure wound therapy to the wound. KulaVAC Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material, and tissue debris. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
    Device Description
    KulaVAC is wound dressing kit for Negative Pressure Wound Therapy (NPWT). The kit consists of individually reviewed medical components; polyurethane foam wound dressing, suction head, tubing, connectors, clamps and acrylic adhesive transparent film. Foam dressing is available in three sizes; small, medium and large, and the other accessories are used to connect to a suction device. The kit is supplied sterile and is single-use.
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