| K-number | K911061 |
| Device name | ESPE KETAC-ENDO APLICAP |
| Applicant | H.A. Opotow Consulting |
| Product code | EMA |
| Device class | Class II |
| Decision date | Jan 3, 1992 |
| Decision | Substantially Equivalent |
| Regulation | 872.3275 |
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