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510(k) Data Aggregation

    K Number
    K980132
    Device Name
    PHYTACARE ALGINATE HYDROGEL WOUND DRESSING
    Manufacturer
    PHYTATEK LABORATORIES, INC.
    Date Cleared
    1998-06-26

    (162 days)

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

    PHYTATEK LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the management of: Diabetic Ulcers, Foot Ulcers, 1st and 2nd Degree Burns, Pressure Ulcers Stages I-IV, Cuts, and Abrasions.
    Device Description
    phytacare™ Alginate Hydrogel Wound Dressings are highly conformable, sterile, primary wound dressings intended to provide a moist environment for the management of moderately exuding, partial to full thickness wounds. There are 2 components of the phytacare™ Alginate Hydrogel Wound Dressing: a standard 12-ply cotton gauze pad and the phytacare™ Alginate Hydrogel. The primary function of the alginate component of the phytacare™ Alginate Hydrogel Wound Dressing is to absorb excess wound exudate, providing a moist wound environment to encourage healing. The phytacare™ Alginate Hydrogel also contains common humectants and moisturizers, thickeners and stabilizers, anti-oxidants, preservatives, and a fragrance. The dressing is packaged in a foil laminate pouch.
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