510(k) K180631 ยท MIX System, Vocal Cord Medialization
Silk Voice
| Applicant | Sofregen Medical, Inc., Medford MA, US |
| Decision | Substantially Equivalent, Nov 8, 2018 |
| Received | Mar 9, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180631
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.