| K-number | K993142 |
| Device name | ELITE CUSTOM |
| Applicant | Soma Blue, Inc. |
| Product code | LKY |
| Device class | Class II |
| Decision date | Dec 27, 1999 |
| Decision | Substantially Equivalent |
| Regulation | 876.5020 |
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