510(k) K043427 ยท GXQ Dura Substitute
DURAGEN II DURAL REGENERATION MATRIX
| Applicant | Integra Lifesciences Corp., Plainsboro NJ, US |
| Decision | Substantially Equivalent, Jan 12, 2005 |
| Received | Dec 13, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043427
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2013 | Integra LifeSciences Corporation Suturable DuraGen Dural Regenerative Matrix
Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, plia Terminated |
GXQ | None listed |
| Mar 11, 2010 | Integra LifeSciences Corp Suturable DuraGen Dural Regeneration Matrix;
Non-Pyrogenic;
Sterility guaranteed unless package is damaged or opened. Rx only.
Manufacturer: Integra LifeSciences Corporation, Plainsboro, NJ 08536
Sut Terminated |
GXQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.