K032116 is an FDA 510(k) clearance for the TULIP COLORSWITCH. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Cavex Holland BV (Haarlem, NL). The FDA issued a Cleared decision on September 30, 2003, 83 days after receiving the submission on July 9, 2003.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K032116 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2003 |
| Decision Date | September 30, 2003 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | ELW — Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |