Device |
bur, ent, diamond coated, single use, reprocessed |
Regulation Description |
Ear, nose, and throat bur. |
Definition |
ENT diamond bur is an accessory to an ENT drill system. It is intended to remove soft and hard tissue during ear, nose and throat surgery. These devices operate at high speed for precise tissue resection. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). |
Product Code | NLZ |
Regulation Number |
874.4140
|
Device Class |
1
|
|
|