| Device |
trocar, tracheal, laryngeal, sinus, reprocessed |
| Regulation Description |
Ear, nose, and throat manual surgical instrument. |
| Definition |
Same as kbg, kab, and kci but need one code for reprocessing. |
| Regulation Medical Specialty |
Ear Nose & Throat |
| Review Panel |
Ear Nose & Throat |
| Product Code | NLB |
| Submission Type |
510(k)
|
| Regulation Number |
874.4420
|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|