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510(k) Data Aggregation

    K Number
    K063517
    Device Name
    HEALADEX-P
    Manufacturer
    HEALAGENICS, INC.
    Date Cleared
    2007-02-16

    (87 days)

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

    HEALAGENICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HEALADEX®-P Wound Dressing provides a moist environment that is supportive of wound healing. HEALADEX-P is indicated for dry, light and moderately exudating partial and full thickness wounds such as: - First and second degree burns - Severe sunburns - Superficial injuries, superficial lacerations, cuts, abrasions, incisions/surgical wounds, and skin tears HEALADEX-P dressing should be used under health care professional direction for the following indications: - Pressure ulcers, Stage I-IV - Lower extremity ulcers - Venous ulcers - Arterial ulcers - Ulcers of mixed etiology - Diabetic ulcers - Donor sites and skin grafts - Burns caused by radiation oncology procedures
    Device Description
    HEALADEX-P is a sterile wound-dressing comprised of carboxymethylcellulose and lyophilized formulated porcine plasma, which is island mounted on moisture vapor permeable adhesive film dressing sheet coated with acrylic adhesive and a polyurethane protective film. This dressing aids the healing process by maintaining a moist environment at the wound site. HEALADEX-P dressing is individually packaged in a foil moisture barrier chevron peel pouch appropriately labeled with lot number and expiration date. Five units are packaged into a cardboard box with Instructions for Use (IFU).
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