Device Type ID | 4308 |
Device Name | Clip, Tantalum, Ophthalmic |
Regulation Description | Ophthalmic Tantalum Clip. |
Regulation Medical Specialty | Ophthalmic |
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) Exempt |
CFR Regulation Number | 886.3100 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | HQW |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4308 |
Device | Clip, Tantalum, Ophthalmic |
Product Code | HQW |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Ophthalmic Tantalum Clip. |
CFR Regulation Number | 886.3100 [🔎] |