510(k) K153076 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL
| Applicant | Teleflexmedical, Inc., Morrisville NC, US |
| Decision | Substantially Equivalent, Jun 16, 2016 |
| Received | Oct 23, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153076
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.