510(k) K003482 ยท LBH Varnish, Cavity
PROCLUDE-SENSITIVE
| Applicant | Ortek Therapeutics, Inc., New York NY, US |
| Decision | Substantially Equivalent, Feb 1, 2001 |
| Received | Nov 9, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003482
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.