Helena Laboratories · Class I · Cleared Nov 27, 1991
| K-number | K913807 |
| Device name | REP(R) SPE TEMPLATE 30, 16, & 8 |
| Applicant | Helena Laboratories |
| Product code | CEF |
| Device class | Class I |
| Decision date | Nov 27, 1991 |
| Decision | Substantially Equivalent |
| Regulation | 862.1630 |
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