Retinalabs.Com · Class I · Cleared May 9, 2000
| K-number | K000457 |
| Device name | VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES |
| Applicant | Retinalabs.Com |
| Product code | HMX |
| Device class | Class I |
| Decision date | May 9, 2000 |
| Decision | Substantially Equivalent |
| Regulation | 886.4350 |
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