510(k) K191103 ยท EJK Liner, Cavity, Calcium Hydroxide
Parkell Desensitizer Gel
| Applicant | Parkell, Inc., Edgewood NY, US |
| Decision | Substantially Equivalent, Nov 22, 2019 |
| Received | Apr 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191103
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.