510(k) K092096 ยท KGN Wound Dressing With Animal-Derived Material(S)
ENDOFORM DERMAL TEMPLATE
| Applicant | Mesynthes, Ltd., North Attleboro MA, US |
| Decision | Substantially Equivalent, Jan 21, 2010 |
| Received | Jul 14, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092096
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2018 | AROA BIOSURGERY Endoform Dermal Template 2x2, SKU 529311
Product Usage:
Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist Terminated |
KGN | None listed |
| Nov 2, 2018 | AROA BIOSURGERY Endoform Dermal Template 2x2, SKU 529312
Product Usage:
Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist Terminated |
KGN | None listed |
| Nov 2, 2018 | AROA BIOSURGERY Endoform Dermal Template 4x5, SKU 529313
Product Usage:
Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist Terminated |
KGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.