| K-number | K152113 |
| Device name | BioHPP - breCAM.BioHPP |
| Applicant | Bredent GmbH & Co. KG |
| Product code | EBF |
| Device class | Class II |
| Decision date | Jul 21, 2016 |
| Decision | Substantially Equivalent |
| Regulation | 872.3690 |
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