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510(k) Data Aggregation
K Number
K090823Device Name
THERAFORM BILAYER
Manufacturer
SEWON CELLONTECH CO., LTD.
Date Cleared
2009-10-22
(210 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SEWON CELLONTECH CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TheraForm™ Bilayer is intended for the management of wounds including:
- Partial and full-thickness wounds .
- Pressure ulcers .
- . Venous ulcers
- Diabetic ulcers .
- Chronic ulcers .
- Surgical wounds (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
TheraForm™ Bilayer Absorbable Collagen Membrane is a sterile, pliable surgical porous scaffold agent made of highly purified collagen derived from porcine skin. TheraForm™ Bilayer is completely absorbable (with the exclusion of silicone layer) and highly biocompatible. The semi-permeable silicone layer helps maintaining moist environment, increases tear strength and provides a flexible adherent covering for the wound surface.
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K Number
K090812Device Name
THERAFORM STANDARD/SHEET
Manufacturer
SEWON CELLONTECH CO., LTD.
Date Cleared
2009-07-30
(127 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SEWON CELLONTECH CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TheraForm™ Standard / Sheet is intended for the management of wounds including:
- Partial and full-thickness wounds .
- Pressure ulcers
- Venous ulcers
- Diabetic ulcers
- Chronic ulcers
- Tunneled / undermined wounds
- Surgical wounds (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
TheraForm™ Standard / Sheet Absorbable Collagen Membrane is a sterile, pliable porous wound dressing made of highly purified collagen derived from porcine. TheraForm™ Standard / Sheet is completely absorbable and highly biocompatible.
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