| K-number | K080873 |
| Device name | OPACITY + BONE CEMENT |
| Applicant | Teknimed, S.A. |
| Product code | NDN |
| Device class | Class II |
| Decision date | Aug 28, 2008 |
| Decision | Substantially Equivalent |
| Regulation | 888.3027 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov