| Device Type ID | 4268 |
| Device Name | Sponge, Ophthalmic |
| Regulation Description | Ophthalmic Sponge. |
| Regulation Medical Specialty | Ophthalmic |
| 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) Exempt |
| CFR Regulation Number | 886.4790 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HOZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 4268 |
| Device | Sponge, Ophthalmic |
| Product Code | HOZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ophthalmic Sponge. |
| CFR Regulation Number | 886.4790 [🔎] |
| Device Problems | |
|---|---|
Difficult To Remove | 1 |
| Total Device Problems | 1 |