510(k) K021889 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)
| Applicant | Surgical Technology Laboratories, Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Oct 16, 2002 |
| Received | Jun 7, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021889
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.