510(k) K850863 ยท EKM Gutta-Percha
ULTRAFIL-LT (GUTTA PERCHA)
| Applicant | The Hygenic Corp., Akron OH, US |
| Decision | Substantially Equivalent, Apr 16, 1985 |
| Received | Mar 1, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850863
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.