510(k) K200125 ยท MQC Mouthguard, Prescription
Thermoforming Sheet Materials
| Applicant | Erkodent Erich Kopp GmbH, Pfalzgrafenweiler, DE |
| Decision | Substantially Equivalent, Oct 28, 2020 |
| Received | Jan 21, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200125
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.