510(k) K081025 ยท KXE Prosthesis, Wrist, Hemi-, Ulnar
ISOELASTICU
| Applicant | Remi Sciences, Inc., Lititz PA, US |
| Decision | Substantially Equivalent, Nov 21, 2008 |
| Received | Apr 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081025
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.