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510(k) Data Aggregation

    K Number
    K131464
    Device Name
    EXTRICARE NPWT FOOT DRESSING
    Manufacturer
    DEVON MEDICAL INC.
    Date Cleared
    2013-08-13

    (84 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    extriCARE® 2400 Negative Pressure Wound Therapy System is a portable, battery powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing.

    Device Description

    extriCARE® Negative Pressure Wound Therapy Foot Dressing

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the ExtriCARE® Negative Pressure Wound Therapy Foot Dressing, confirming its substantial equivalence to a predicate device. It discusses regulatory compliance and general information but does not detail device performance or studies in the way you have requested.

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