510(k) K970930 ยท DYJ Retainer, Screw Expansion, Orthodontic
BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE
| Applicant | Cleft Palate Appliances, Inc., London, CA |
| Decision | Substantially Equivalent, Apr 23, 1997 |
| Received | Mar 13, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970930
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.