NLOClass II
Drills, Burrs, Trephines And Accessories (Manual), Reprocessed
21 CFR 882.4300 / Neurology
NLO is the FDA product code for Drills, Burrs, Trephines And Accessories (Manual), Reprocessed, a class II device type, regulated under 21 CFR 882.4300. FDA's definition for this code reads: "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)". As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- NLO
- Device name
- Drills, Burrs, Trephines And Accessories (Manual), Reprocessed
- FDA 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).
- Regulation
- 21 CFR 882.4300
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code NLO.
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