510(k) K100545 ยท OBR Mouthguard, Over-The-Counter
SLEEPRIGHT
| Applicant | Power Products, Inc.-Splintek, Lenexa KS, US |
| Decision | Substantially Equivalent, Jun 4, 2010 |
| Received | Feb 26, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100545
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.