510(k) K212017 ยท MQC Mouthguard, Prescription
Thermeo System
| Applicant | Pro3Dure Medical GmbH, Iserlohn, DE |
| Decision | Substantially Equivalent, Apr 8, 2022 |
| Received | Jun 28, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212017
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.