510(k) K110468 ยท MQC Mouthguard, Prescription
FREEWAY COMFORT BITE GUARD
| Applicant | Randmark Dental Products, LLC, Potomac MD, US |
| Decision | Substantially Equivalent, Aug 5, 2011 |
| Received | Feb 17, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110468
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.