510(k) K180992 ยท NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Biotex
| Applicant | Purgo Biologics, Inc., Seongnam-Si, KR |
| Decision | Substantially Equivalent, Jul 16, 2019 |
| Received | Apr 16, 2018 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K180992
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.