510(k) K032693 ยท GXQ Dura Substitute
DURAGEN PLUS DURAL GRAFT MATRIX
| Applicant | Integra Lifesciences Corp., Planisboro NJ, US |
| Decision | Substantially Equivalent, Sep 30, 2003 |
| Received | Sep 2, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032693
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2013 | Integra LifeSciences Corporation DuraGen Plus Dural Regeneration Matrix
DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridu Terminated |
GXQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.