| K-number | K010937 |
| Device name | SEP-10S PLUS, AND SP-12S PRO. |
| Applicant | Viltechmeda |
| Product code | FRN |
| Device class | Class II |
| Decision date | Jun 25, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 880.5725 |
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