Product code NLO
- Device name
- Drills, Burrs, Trephines And Accessories (Manual), Reprocessed
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4300
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- 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).
- Source
- FDA openFDA device classification dataset