K022430 is an FDA 510(k) clearance for the ISO FUNCTIONAL. 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 October 18, 2002, 85 days after receiving the submission on July 25, 2002.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K022430 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2002 |
| Decision Date | October 18, 2002 |
| Days to Decision | 85 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 |