510(k) K072113 ยท KGN Wound Dressing With Animal-Derived Material(S)
INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
| Applicant | Integra Lifesciences Corp., Plainsboro NJ, US |
| Decision | Substantially Equivalent, Oct 10, 2007 |
| Received | Aug 1, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072113
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2019 | Integra Limited Integra Flowable Wound Matrix
Catalog No: FWD301
Product Usage:
Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor si Terminated |
KGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.