510(k) K081816 ยท MIX System, Vocal Cord Medialization
VOCALIS AND VOCALIS SM
| Applicant | Cytophil, Inc., Whitefish Bay WI, US |
| Decision | Substantially Equivalent, Jan 5, 2009 |
| Received | Jun 26, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081816
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.