510(k) K931615 ยท KMY Positioner, Tooth, Preformed
NITE-GUIDE
| Applicant | ORTHO-TAIN, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Apr 14, 1995 |
| Received | Apr 1, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931615
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.