510(k) K904111 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
HTR POLYMER, HTR-MX
| Applicant | United States Surgical, A Division of Tyco Healthc, Norwalk CT, US |
| Decision | Substantially Equivalent, Nov 23, 1990 |
| Received | Sep 6, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904111
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.