510(k) K192490 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch
| Applicant | Teleflex Medical, Morrisville NC, US |
| Decision | Substantially Equivalent, Mar 30, 2020 |
| Received | Sep 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192490
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.