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510(k) Data Aggregation

    K Number
    K101546
    Device Name
    ENDOFORM DENTAL TEMPLATE
    Manufacturer
    MESYNTHES LTD
    Date Cleared
    2010-06-23

    (20 days)

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

    MESYNTHES LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endoform™ Dermal Template is supplied sterile and is intended for single use in the treatment of the following wounds: - partial and full-thickness wounds . - pressure ulcers . - . venous ulcers - diabetic ulcers . - chronic vascular 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
    The Endoform™ Dermal Template is a wound care device comprised of one or two layers of ovine extracellular matrix and is supplied as a sterile perforated or non perforated sheet ranging in size up to 400 cm2.
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    K Number
    K092096
    Device Name
    ENDOFORM DERMAL TEMPLATE
    Manufacturer
    MESYNTHES LTD
    Date Cleared
    2010-01-21

    (191 days)

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

    MESYNTHES LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endoform™ Dermal Template is supplied sterile and is intended for single use in the treatment of the following wounds: - partial and full-thickness wounds - pressure ulcers - venous ulcers - diabetic ulcers - chronic vascular 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
    Endoform™ Dermal Template is a wound dressing primarily composed of ovine collagen and is supplied as a sterile intact, perforated or meshed sheet ranging in size from 9cm2 to 400cm2.
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