510(k) K033398 ยท MIX System, Vocal Cord Medialization
LARYNGEAL AUGMENTATION IMPLANT
| Applicant | Bioform, Inc., San Mateo CA, US |
| Decision | Substantially Equivalent, Dec 12, 2003 |
| Received | Oct 24, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033398
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.