Helena Laboratories · Class I · Cleared Jan 13, 1997
| K-number | K962914 |
| Device name | REP 3 QUTO-FLUR CHOLESTEROL-30 |
| Applicant | Helena Laboratories |
| Product code | JHO |
| Device class | Class I |
| Decision date | Jan 13, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 862.1475 |
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