510(k) K964656 ยท NPK Barrier, Synthetic, Intraoral
TEFGEN GUIDED TISSUE MEMBRANE
| Applicant | American Custom Medical, Inc., Bozeman MT, US |
| Decision | Substantially Equivalent, Feb 10, 1997 |
| Received | Nov 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964656
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.