510(k) K983525 ยท MIX System, Vocal Cord Medialization
GORE REVOX THYROPLASTY IMPLANT
| Applicant | W. L. Gore & Associates, Inc., Elkton MD, US |
| Decision | Substantially Equivalent, Dec 10, 1998 |
| Received | Oct 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983525
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.