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510(k) Data Aggregation

    K Number
    K090894
    Device Name
    COLLAWOUND WOUND DRESSING
    Manufacturer
    COLLAMATRIX CO., INC.
    Date Cleared
    2009-06-25

    (86 days)

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

    COLLAMATRIX CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CollaWound wound dressing is intended for the management of wounds including: - partial and full-thickness wounds - diabetic ulcers - venous ulcers - pressure ulcers - chronic vascular ulcers - tunneled/undermined wounds - surgical wounds (donor site/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence) - trauma wounds (abrasions, lacerations, secondary-degree burns, and skin tears) - draining wounds
    Device Description
    CollaWound wound dressing is a sterile, single use, disposable wound dressing comprised of cross-linked porous collagen matrix with yellow to off-yellow appearance and is supplied in sponge configuration. It forms a layer of thin film at the wound site and provides a biodegradable scaffold for the cell invasion and capillary growth.
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    K Number
    K071557
    Device Name
    COLLAWOUND HYDROGEL
    Manufacturer
    COLLAMATRIX CO., INC.
    Date Cleared
    2008-02-08

    (246 days)

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

    COLLAMATRIX CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CollaWound™ Hydrogel is intended for the management of partial and full thickness wounds, pressure ulcers, diabetic ulcers, venous ulcers, surgical wounds, first and second degree burns, superficial injuries, cuts and abrasions.
    Device Description
    CollaWound™ Hydrogel is a collagen-based emulsion/liquid formulation comprising collagen derived from porcine hides. It is intended for the management of partial and full thickness wounds, pressure ulcers, diabetic ulcers, venous ulcers, surgical wounds, first and second degree burns, superficial injuries, cuts and abrasions.
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    K Number
    K070269
    Device Name
    MODIFICATION TO COLLAWOUND DRESSING
    Manufacturer
    COLLAMATRIX CO., INC.
    Date Cleared
    2007-03-02

    (32 days)

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

    COLLAMATRIX CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CollaWound™ dressing is intended for the management of partial and full-thickness exudating wounds including: - Pressure ulcers - Venous ulcers - Vascular ulcers - Diabetic ulcers - Trauma wounds (abrasions, lacerations, skin tears) - First and second degree burns - Surgical wounds
    Device Description
    CollaWound™ dressing is a sterile, single use, disposable wound dressing device for the management of exudating wounds. It comprises collagen derived from porcine, which forms a layer of thin film to maintain a moist environment at the wound site.
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    K Number
    K061474
    Device Name
    COLLAWOUND DRESSING
    Manufacturer
    COLLAMATRIX CO., INC.
    Date Cleared
    2006-07-05

    (36 days)

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

    COLLAMATRIX CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CollaWound™ dressing is intended for the management of partial and full-thickness exudating wounds including: - Pressure ulcers - Venous ulcers - Vascular ulcers - Diabetic ulcers - Trauma wounds (abrasions, lacerations, skin tears) - First and second degree burns - Surgical wounds
    Device Description
    CollaWound™ dressing is a sterile, single use, disposable wound dressing device for the management of exudating wounds. It comprises insoluble fibrous collagen derived from porcine with white to off-white appearance, which forms a layer of thin film by maintaining a moist environment at the wound site.
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