510(k) K021792 ยท KGN Wound Dressing With Animal-Derived Material(S)
BILAYER MATRIX WOUND DRESSING
| Applicant | Integra Lifesciences Corp., Planisboro NJ, US |
| Decision | Substantially Equivalent, Aug 14, 2002 |
| Received | May 31, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021792
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2009 | Integra LifeSciences Corp. Integra Bilayer Matrix Wound Dressing, 8 in X 10 in (20 cm x 25 cm); Non-pyrogenic, Do not Re sterilize, Store flat at room temperature, Avoid Excessive heat, Avoid freezing. Sterile. Catalog number Terminated |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.