Definition: Needle For Phacoemulsification Device To Remove Cataractous Lens. Same As Needle For Main Phacoemulsification Device And Un-reprocessed Needle With Product Code HQC, Except This Is A "reprocessed" Needle. The Phacoemulsification Device Is NOT Reproce
| Device Type ID | 4382 |
| Device Name | Needle, Phacoemulsification, Reprocessed |
| Regulation Description | Phacofragmentation System. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 886.4670 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NKX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4382 |
| Device | Needle, Phacoemulsification, Reprocessed |
| Product Code | NKX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Phacofragmentation System. |
| CFR Regulation Number | 886.4670 [🔎] |