510(k) K173644 ยท GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Gazelle Polypropylene Suture and Delivery Device
| Applicant | Dura Tap, LLC, Wayne PA, US |
| Decision | Substantially Equivalent, Feb 15, 2018 |
| Received | Nov 27, 2017 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K173644
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.