510(k) K121795 ยท MIX System, Vocal Cord Medialization
CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT
| Applicant | Cytophil, Inc., East Troy WI, US |
| Decision | Substantially Equivalent, Feb 22, 2013 |
| Received | Jun 19, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121795
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.