Helena Laboratories · Class I · Cleared Aug 31, 1989
| K-number | K894366 |
| Device name | REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 |
| Applicant | Helena Laboratories |
| Product code | LBT |
| Device class | Class I |
| Decision date | Aug 31, 1989 |
| Decision | Substantially Equivalent |
| Regulation | 862.1475 |
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