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510(k) Data Aggregation

    K Number
    K081724
    Device Name
    HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSAMINOGLYCAN) WOUND GEL
    Manufacturer
    APPLIED NUTRITIONALS
    Date Cleared
    2008-10-30

    (134 days)

    Product Code
    KGN
    Regulation Number
    N/A
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    Applicant Name (Manufacturer) :

    APPLIED NUTRITIONALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound gel is indicated for topical use in the management of chronic and acute wounds and dermal ulcers including the local management of: - Pressure Ulcers (Stage I-IV) - Venous Stasis Ulcers - Diabetic Ulcers - First and Second Degrec Burns - Surgical wounds - Traumatic wounds - Superficial wounds - Ulcers resulting from arterial insufficiency - Grafted wounds and donor sites For over the counter use, Hydrolyzed Collagen with 10% Chondroiiin Sulfate Wound Gel may be used for: - minor abrasions - laccrations - minor cuts - minor scalds and burns
    Device Description
    Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) Wound Gel is a line extension of the previously approved HyCure® Hydrolyzed Collagen (K955506). Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) contains Chondroitin Sulfate as Chondroprotec® previously approved for market via 510(k) (K961930). Hydrolyzed Collagcn with 10% Chondroitin Sulfate Wound Gel contains a high concentration of water bound to the hydrolyzed collagen which maintains a moist wound environment as it manages wound healing. Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) Wound gel is provided in a patient ready, one (1) ounce, collapsible tube.
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