K943388 is an FDA 510(k) clearance for the GC SURFLEX F. 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 September 12, 1994, 61 days after receiving the submission on July 13, 1994.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K943388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1994 |
| Decision Date | September 12, 1994 |
| Days to Decision | 61 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 |