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510(k) Data Aggregation

    K Number
    K002896
    Device Name
    ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING
    Manufacturer
    THE WESTAIM CORP.
    Date Cleared
    2001-02-21

    (156 days)

    Product Code
    FRO, KMF
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE WESTAIM CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acticoat® Calcium Alginate Dressing is an effective barrier to bacterial penetration. The barrier functions of the dressing may help reduce infection in moderate to heavily exudative partial and full thickness wounds including decubitus ulcers, diabetic ulcers, venous stasis ulcers, surgical and traumatic wounds. Acticoat® dressings may be used over debrided and partial thickness wounds.
    Device Description
    The Acticoat® Calcium Alginate Dressing is a highly absorbent non-woven calcium alginate fabric with an Acticoat® coating applied directly to its surface. It has a light grey appearance. Formatted in various sizes (5cm x 5cm, 10cm x 12.5cm, 15cm x 15cm, and a 2.5cm x 30cm rope) and packaged in Tyvek pouches.
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