NLN — Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed Class II
FDA product code NLN covers "Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed", a Class II medical device regulated under 21 CFR 882.4310. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NLN
- Device Class
- Class II
- Regulation Number
- 882.4310
- 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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K041978 | alliance medical | REPROCESSED DIAMOND BURS | November 23, 2004 |