| K-number | K972015 |
| Device name | HYDRAGEL 7,15,30, CHOL-HDL KIT |
| Applicant | Morax |
| Product code | LBT |
| Device class | Class I |
| Decision date | Oct 27, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 862.1475 |
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