Device |
knife, ophthalmic, reprocessed |
Definition |
Used for cutting soft tissue in or around the eye. Surgical knife same as product code HNN, except this one is reprocessed. 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 | NLA |
Regulation Number |
886.4350
|
Device Class |
1
|
|
|