510(k) K063778 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE
| Applicant | Teleflex Medical, Bannockburn IL, US |
| Decision | Substantially Equivalent, Feb 9, 2007 |
| Received | Dec 21, 2006 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K063778
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2014 | Teleflex Medical Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico.
Indicated for use in soft tissue approximation. Terminated |
GAT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.