510(k) K110378 ยท ELW Material, Impression
IMPRESSION COMPOUND
| Applicant | Spofadental, Orange CA, US |
| Decision | Substantially Equivalent, Apr 5, 2011 |
| Received | Jan 12, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110378
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.