510(k) K042878 ยท ELW Material, Impression
FLEXITIME XTREME
| Applicant | Heraeus Kulzer, Inc., South Bend IN, US |
| Decision | Substantially Equivalent, Dec 17, 2004 |
| Received | Oct 18, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042878
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.