510(k) K010936 ยท OXD Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement
MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, May 21, 2001 |
| Received | Mar 28, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010936
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.