| K-number | K790566 |
| Device name | PACEMAKER, OVALITH-D CARDIAC |
| Applicant | Caratomic |
| Product code | DXY |
| Device class | Class III |
| Decision date | Mar 19, 1979 |
| Decision | Substantially Equivalent — with Special Conditions |
| Regulation | 870.3610 |
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