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510(k) Data Aggregation
K Number
K101546Device Name
ENDOFORM DENTAL TEMPLATE
Manufacturer
MESYNTHES LTD
Date Cleared
2010-06-23
(20 days)
Product Code
KGN
Regulation Number
N/AWhy 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
K092096Device Name
ENDOFORM DERMAL TEMPLATE
Manufacturer
MESYNTHES LTD
Date Cleared
2010-01-21
(191 days)
Product Code
KGN
Regulation Number
N/AWhy 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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