510(k) K001434 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE
| Applicant | Genzyme Surgical Product (Genzyme Biosurgery), Fall River MA, US |
| Decision | Substantially Equivalent for Some Indications, Jun 12, 2000 |
| Received | May 8, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001434
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2007 | Teleflex Creek Dr Various Types and Sizes of Polyethylene Synthetic Nonabsorable Sutures-Polyester, TEV GN BR 0 TC-43/HR 262N, Catalog #833-114 Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.