NLN
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4310
- Medical specialty
- Neurology
- Flags
- Third-party review eligible
- 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).
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| REPROCESSED DIAMOND BURS (K041978) | Alliance Medical Corp. | 2004-11-23 |
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