K970656 is an FDA 510(k) clearance for the HYDROFLEX. 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 April 8, 1997, 46 days after receiving the submission on February 21, 1997.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K970656 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 1997 |
| Decision Date | April 08, 1997 |
| Days to Decision | 46 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 |