510(k) K161884 ยท MQC Mouthguard, Prescription
Ortho System
| Applicant | 3Shape A/S, Copenhagen, DK |
| Decision | Substantially Equivalent, Apr 19, 2017 |
| Received | Jul 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161884
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.