510(k) K063194 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
TUFFLEX POLYESTER SUTURE
| Applicant | Axya Medical, Inc., Beverly MA, US |
| Decision | Substantially Equivalent, Dec 4, 2006 |
| Received | Oct 20, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063194
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.