510(k) K864181 ยท JXL Block, Bite
SOMATICS MOUTH GUARD (BITE BLOCK)
| Applicant | Somatics, Inc., Lake Bluff IL, US |
| Decision | Substantially Equivalent, Nov 3, 1986 |
| Received | Oct 27, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864181
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.