510(k) K010957 ยท LBH Varnish, Cavity
QUELL DESENSITIZER
| Applicant | Jeneric/Pentron, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Jun 25, 2001 |
| Received | Mar 30, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010957
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.