510(k) K211307 ยท NWJ Suture, Recombinant Technology
GalaSTITCH Absorbable Monofilament Suture
| Applicant | Tepha, Inc., Lexington MA, US |
| Decision | Substantially Equivalent, May 27, 2021 |
| Received | Apr 29, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211307
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.