510(k) K191361 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
DemeDIOX Barbed Absorbable Surgical Suture
| Applicant | Demetech Corporation, Miami Lakes FL, US |
| Decision | Substantially Equivalent, Nov 7, 2019 |
| Received | May 21, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191361
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.