510(k) K053516 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
MUCOHARD
| Applicant | Parkell, Inc., Farmingdale NY, US |
| Decision | Substantially Equivalent, Jan 26, 2006 |
| Received | Dec 16, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053516
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.