510(k) K082301 ยท OBR Mouthguard, Over-The-Counter
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| Applicant | Placontrol, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Oct 6, 2008 |
| Received | Aug 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082301
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.