510(k) K043295 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
VERSYO.DIRECT
| Applicant | Heraeus Kulzer, Inc., South Bend IN, US |
| Decision | Substantially Equivalent, Jan 5, 2005 |
| Received | Nov 29, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043295
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.