K041978 is an FDA 510(k) clearance for the REPROCESSED DIAMOND BURS. This device is classified as a Drills, Burrs, Trephines And Accessories (simple Powered), Reprocessed (Class II - Special Controls, product code NLN).
Submitted by Alliance Medical Corp. (Phoenix, US). The FDA issued a Cleared decision on November 23, 2004, 123 days after receiving the submission on July 23, 2004.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4310. 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)..
| 510(k) Number | K041978 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2004 |
| Decision Date | November 23, 2004 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NLN — Drills, Burrs, Trephines And Accessories (simple Powered), Reprocessed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4310 |
| 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). |