| K-number | K110480 |
| Device name | PDE PHOTODYNAMIC EYE |
| Applicant | Hamamatsu Photonics K.K. |
| Product code | OWN |
| Device class | Class II |
| Decision date | Jan 13, 2012 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
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