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510(k) Data Aggregation

    K Number
    K090823
    Device Name
    THERAFORM BILAYER
    Manufacturer
    SEWON CELLONTECH CO., LTD.
    Date Cleared
    2009-10-22

    (210 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why 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
    K090812
    Device Name
    THERAFORM STANDARD/SHEET
    Manufacturer
    SEWON CELLONTECH CO., LTD.
    Date Cleared
    2009-07-30

    (127 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why 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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