510(k) K070644 ยท FTL Mesh, Surgical, Polymeric
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
| Applicant | W. L. Gore & Associates, Inc., Elkton MD, US |
| Decision | Substantially Equivalent, Apr 2, 2007 |
| Received | Mar 8, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070644
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.