510(k) K965205 ยท NPK Barrier, Synthetic, Intraoral
TEFGEN - LS
| Applicant | American Custom Medical, Inc., Bozeman MT, US |
| Decision | Substantially Equivalent, Apr 30, 1997 |
| Received | Dec 26, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965205
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.