510(k) K151149 ยท OBR Mouthguard, Over-The-Counter
Ready-Fit
| Applicant | Den Tek Oral Care, Inc., Maryville TN, US |
| Decision | Substantially Equivalent, Sep 30, 2015 |
| Received | Apr 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151149
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.