| Device Type ID | 4435 |
| Device Name | Cup, Eye |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Contact Lenses And Retinal Devices Branch (CLRD) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | LXQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4435 |
| Device | Cup, Eye |
| Product Code | LXQ |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
APOTHECARY PRODUCTS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DYNAREX | ||
SUBSTANTIALLY EQUIVALENT | 1 | |