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510(k) Data Aggregation
K Number
K112580Device Name
COLLAGEN WOUND DRESSING
Manufacturer
DALIM TISSEN CO., LTD.
Date Cleared
2012-06-01
(269 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DALIM TISSEN CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collagen Wound Dressing is intended use for management of partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, tunneled / undermined wounds, surgical wound (donor sites / grafts, post-moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), draining wounds.
Device Description
Collagen Wound Dressing (Absorbable Collagen Membrane) is a sterile, pliable porous and dense wound dressing made of highly purified collagen derived from porcine skin. It is crosslinked using 1-ethyl-3-(3-dimethyl aminopropyl) carbodiimide (EDC) for the resistance to enzymatic degradation. Collagen Wound Dressing is completely absorbable and highly biocompatible. Collagen Wound Dressing is composed of porous sponge layer for the wound surface and dense film layer for protecting wound from outside.
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