510(k) K974311 ยท KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT
| Applicant | Gyrus Ent LLC, Bartlett TN, US |
| Decision | Substantially Equivalent, Mar 4, 1998 |
| Received | Nov 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974311
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.