510(k) K192088 ยท NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
GOLNIT Non-aborbable PTFE Surgical Suture
| Applicant | Antarma, LLC Dba Golnit Sutures, New York NY, US |
| Decision | Substantially Equivalent, Sep 4, 2019 |
| Received | Aug 5, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192088
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.