510(k) K000533 ยท MIX System, Vocal Cord Medialization
VOCOM IMPLANT- 8MM
| Applicant | Smith & Nephew, Inc., Bartlett TN, US |
| Decision | Substantially Equivalent, Mar 1, 2000 |
| Received | Feb 17, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000533
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.