510(k) K982180 ยท GXQ Dura Substitute
DURAGEN DURAL GRAFT MATRIX
| Applicant | Integra Lifesciences Corp., Plainsboro NJ, US |
| Decision | Substantially Equivalent, Jul 6, 1999 |
| Received | Jun 22, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982180
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2013 | Integra LifeSciences Corporation Dural Graft Matrix
DuraGen Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. Dur Terminated |
GXQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.