K073678 is an FDA 510(k) clearance for the VARIOSURG. This device is classified as a Drill, Bone, Powered (Class II - Special Controls, product code DZI).
Submitted by Nakanishi, Inc. (Washington, US). The FDA issued a Cleared decision on July 10, 2008, 195 days after receiving the submission on December 28, 2007.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K073678 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2007 |
| Decision Date | July 10, 2008 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | DZI — Drill, Bone, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |