510(k) K935137 ยท NPK Barrier, Synthetic, Intraoral
TEFGEN-FD
| Applicant | American Custom Medical, Inc., Lubbock TX, US |
| Decision | Substantially Equivalent, Aug 15, 1994 |
| Received | Oct 28, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935137
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Lifecore Biomedical, Inc. TefGen is an implant material which is intended to be used as a temporary space-making barrier over bone or other tissue. Terminated |
LYC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.