510(k) K083209 ยท LRK Device, Anti-Snoring
ACRYLIC HERBST SPLINT APPLIANCE
| Applicant | Specialty Appliance Works, Inc., Cumming GA, US |
| Decision | Substantially Equivalent, Jan 27, 2009 |
| Received | Oct 31, 2008 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K083209
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.