K961648 is an FDA 510(k) clearance for the THE WAND. This device is classified as a Syringe, Cartridge (Class II - Special Controls, product code EJI).
Submitted by Spintech, Inc. (Washington, US). The FDA issued a Cleared decision on July 5, 1996, 67 days after receiving the submission on April 29, 1996.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6770.
| 510(k) Number | K961648 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 1996 |
| Decision Date | July 05, 1996 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EJI - Syringe, Cartridge |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6770 |