K041398 is an FDA 510(k) clearance for the GC FUSION. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on June 25, 2004, 30 days after receiving the submission on May 26, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K041398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2004 |
| Decision Date | June 25, 2004 |
| Days to Decision | 30 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 |