510(k) K123161 ยท MQC Mouthguard, Prescription
SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE
| Applicant | Smartguard, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Mar 14, 2013 |
| Received | Oct 9, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123161
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.