510(k) K112868 ยท MQC Mouthguard, Prescription
DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX
| Applicant | Dreamgard, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Jan 19, 2012 |
| Received | Sep 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112868
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.