| Device |
needle, phacoemulsification, reprocessed |
| Regulation Description |
Phacofragmentation system. |
| 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 reprocessed, just the needle. |
| Regulation Medical Specialty |
Ophthalmic |
| Review Panel |
Ophthalmic |
|---|
| Product Code | NKX |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
886.4670
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
