Device Type ID | 4442 |
Device Name | Solution, Cleaning / Lubricating, Artificial 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 | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | MSI |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4442 |
Device | Solution, Cleaning / Lubricating, Artificial Eye |
Product Code | MSI |
FDA Device Classification | Class 3 Medical Device |