Helena Laboratories · Class I · Cleared Aug 18, 1992
| K-number | K922053 |
| Device name | REP SPE PLUS (PONCEAU S) SYSTEM |
| Applicant | Helena Laboratories |
| Product code | CEF |
| Device class | Class I |
| Decision date | Aug 18, 1992 |
| Decision | Substantially Equivalent |
| Regulation | 862.1630 |
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