510(k) K890494 ยท EBC Sealant, Pit And Fissure, And Conditioner
FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS
| Applicant | Macrochem Corp., Billerica MA, US |
| Decision | Substantially Equivalent, Mar 29, 1989 |
| Received | Jan 31, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K890494
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.