510(k) K173335 ยท NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Gazelle PTFE and Suture Delivery Device
| Applicant | Dura Tap, LLC, Wayne PA, US |
| Decision | Substantially Equivalent, Feb 8, 2018 |
| Received | Oct 23, 2017 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K173335
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.