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Found 4 results
510(k) Data Aggregation
K Number
K090894Device Name
COLLAWOUND WOUND DRESSING
Manufacturer
COLLAMATRIX CO., INC.
Date Cleared
2009-06-25
(86 days)
Product Code
FRO
Regulation Number
N/AWhy 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
K071557Device Name
COLLAWOUND HYDROGEL
Manufacturer
COLLAMATRIX CO., INC.
Date Cleared
2008-02-08
(246 days)
Product Code
FRO
Regulation Number
N/AWhy 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
K070269Device Name
MODIFICATION TO COLLAWOUND DRESSING
Manufacturer
COLLAMATRIX CO., INC.
Date Cleared
2007-03-02
(32 days)
Product Code
KGN, CLA
Regulation Number
N/AWhy 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
K061474Device Name
COLLAWOUND DRESSING
Manufacturer
COLLAMATRIX CO., INC.
Date Cleared
2006-07-05
(36 days)
Product Code
KGN
Regulation Number
N/AWhy 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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