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510(k) Data Aggregation

    K Number
    K123756
    Device Name
    COVAGEN
    Date Cleared
    2013-08-16

    (252 days)

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

    COVALON TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ColActive® Transfer is indicated for management of full and partial thickness wounds including: pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular etiologies, venous ulcers, second degree burns, donor and graft sites, abrasions, dehisced surgical wounds, traumatic wounds healing by secondary intention.
    Device Description
    ColActive® Transfer is a modification to the existing ColActive® Collagen Wound Dressing previously cleared under K050177 on 27th April 2005. ColActive® Transfer is composed of the same base matrix material; collagen and sodium alginate and is made from substantially an equivalent manufacturing process as the predicate. The new product, ColActive® Transfer is a pliable, absorbent, perforated, and biocompatible dressing. ColActive® Transfer dressings absorb and transfer moisture such as wound fluid and maintains a moist environment at the wound surface. The dressings can be cut to fit specific wounds and can be layered for the management of deep wounds. ColActive® Transfer dressings contain multiple holes that are evenly distributed across the surface area in order to facilitate the movement of excess exudates through the dressing and away from the wound. The new product will be supplied sterile packaged in a single use heat sealed medical grade foil pouch. The single use primaries will be packed, with a product insert, into cartons for distribution.
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    K Number
    K060804
    Device Name
    COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING
    Date Cleared
    2006-04-18

    (25 days)

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

    COVALON TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Collagran wound dressing and Collagran Ag wound dressing are intended to be used for the following conditions: the management of full and partial thickness wounds including: pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular etiologies, venous ulcers, first and second degree burns, donor and graft sites, abrasions and lacerations, dehisced surgical wounds, traumatic wounds healing by secondary intention
    Device Description
    Not Found
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    K Number
    K052696
    Device Name
    COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSING
    Date Cleared
    2006-02-03

    (128 days)

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

    COVALON TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CovaClearAg™ Collagen with Silver, Antimicrobial Gel Sheet Dressing is indicated for the management of full and partial thickness wounds including: Pressure ulcers, Diabetic ulcers, Ulcers caused by mixed vascular etiologies, Venous ulcers, Donor and Graft sites, Abrasions and lacerations, Traumatic wounds healing by secondary intention, Dehisced surgical wounds, First & Second degree burns.
    Device Description
    CovaClearAg™ Collagen with Silver, Antimicrobial, Gel Sheet Dressing is an advanced wound care dressing composed of collagen and silver lactate provided in a sterile sheet. CovaClearAg™ Collagen with Silver. Antimicrobial Dressings are pliable, hydrated collagen sheets that maintain a moist environment at the wound surface that aids in the formation of granulation tissue and epithelialization. Because of its significant water content (77.5%), the dressing provides hydration to the wound surface. The dressings act as an effective barrier to bacterial and fungal penetration. The silver content is intended to prevent colonization of the dressing. The dressings can be cut to fit specific wounds and can be layered for the management of deep wounds.
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