| K-number | K973926 |
| Device name | O BUTMENT HS IMPLANT |
| Applicant | O Co., Inc. |
| Product code | DZE |
| Device class | Class II |
| Decision date | Jan 5, 1998 |
| Decision | Substantially Equivalent |
| Regulation | 872.3640 |
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