NLO — Drills, Burrs, Trephines And Accessories (Manual), Reprocessed Class II
FDA product code NLO covers "Drills, Burrs, Trephines And Accessories (Manual), Reprocessed", a Class II medical device regulated under 21 CFR 882.4300. Submissions are reviewed by the Neurology panel.
Classification Details
- Product Code
- NLO
- Device Class
- Class II
- Regulation Number
- 882.4300
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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).