510(k) K050013 ยท ELW Material, Impression
RETRACTOFOAM
| Applicant | Coltene/Whaledent AG, New York NY, US |
| Decision | Substantially Equivalent, Feb 9, 2005 |
| Received | Jan 3, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050013
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.