510(k) K973539 ยท EJK Liner, Cavity, Calcium Hydroxide
ROEKO CALCIUM HYDROXIDE POINTS
| Applicant | Roeko USA, Inc., Concord MA, US |
| Decision | Substantially Equivalent, Oct 30, 1997 |
| Received | Sep 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973539
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.