Helena Laboratories · Class II · Cleared Jul 6, 2006
| K-number | K061069 |
| Device name | SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 |
| Applicant | Helena Laboratories |
| Product code | CFF |
| Device class | Class II |
| Decision date | Jul 6, 2006 |
| Decision | Substantially Equivalent |
| Regulation | 866.5510 |
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