510(k) K121365 ยท MQC Mouthguard, Prescription
THERMOFORMED MOUTHGUARDS
| Applicant | Glidewell Laboratories-Sleep Devices Group, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 20, 2012 |
| Received | May 7, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121365
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.