510(k) K011130 ยท ELM Denture, Plastic, Teeth
PREMIUM
| Applicant | Heraeus Kulzer, Inc., Armonk NY, US |
| Decision | Substantially Equivalent, Jul 5, 2001 |
| Received | Apr 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011130
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.