| K-number | K945627 |
| Device name | PIKOS LP 01, PIKOS LP E01 |
| Applicant | Biotronik, Inc. |
| Product code | DXY |
| Device class | Class III |
| Decision date | Mar 4, 1996 |
| Decision | Substantially Equivalent — with Special Conditions |
| Regulation | 870.3610 |
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