| Proprietary Name: | EYEMAX |
| Classification Name: | PAD, NEONATAL EYE |
| Product Code: | FOK |
| Device Class: | 1 |
| Regulation Number: | 880.5270 |
| Medical Specialty: | General Hospital |
| Registered Establishment Name: | MAXTEC, LLC |
| Registered Establishment Number: | 1722070 |
| Owner/Operator: | MAXTEC, LLC |
| Owner/Operator Number: | 9042996 |
| Establishment Operations: | Manufacturer |