NLN
- Product code
- NLN
- Device name
- Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.4310
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
FDA classification definition
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).
Official FDA classification page: NLN
Classification and pathway per current FDA publications. Data from openFDA (CC0).