510(k) K002989 ยท EJR Agent, Polishing, Abrasive, Oral Cavity
PROCLUDE
| Applicant | Ortek Therapeutics, Inc., New York NY, US |
| Decision | Substantially Equivalent, Dec 14, 2000 |
| Received | Sep 25, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002989
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.