| K-number | K982537 |
| Device name | TOKUYAMA SOFRELINER |
| Applicant | Tokuyama America, Inc. |
| Product code | EBI |
| Device class | Class II |
| Decision date | Aug 24, 1998 |
| 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