510(k) K964867 ยท KLE Agent, Tooth Bonding, Resin
HYBRID RESIN COMPOSITE
| Applicant | Parkell, Inc., Farmingdale NY, US |
| Decision | Substantially Equivalent, Apr 11, 1997 |
| Received | Dec 5, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964867
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.