| K-number | K831095 |
| Device name | ROYALE II |
| Applicant | Factor, Ii, Inc. |
| Product code | EBI |
| Device class | Class II |
| Decision date | Aug 31, 1983 |
| Decision | Substantially Equivalent |
| Regulation | 872.3760 |
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