Device Type ID | 4436 |
Device Name | Media, Corneal Storage |
Review Panel | Ophthalmic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Intraocular And Corneal Implants Devices Branch (ICIB) |
Submission Type | 510(k) |
FDA Device Classification | Class Unclassified Medical Device |
Product Code | LYX |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4436 |
Device | Media, Corneal Storage |
Product Code | LYX |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
EUROBIO | ||
SUBSTANTIALLY EQUIVALENT | 1 |