510(k) K182672 ยท NJM Bracket, Ceramic, Orthodontic
ROSA Bracket
| Applicant | Gni Co., Ltd., Hwaseong, KR |
| Decision | Substantially Equivalent, Nov 15, 2019 |
| Received | Sep 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182672
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.