510(k) K974865 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
CSR
| Applicant | Parkell, Inc., Farmingdale NY, US |
| Decision | Substantially Equivalent, Mar 16, 1998 |
| Received | Dec 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974865
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.