K935151 is an FDA 510(k) clearance for the HYDROCOLLOID HEATING UNIT. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on April 4, 1994, 158 days after receiving the submission on October 28, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K935151 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1993 |
| Decision Date | April 04, 1994 |
| Days to Decision | 158 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 |