K823008 is an FDA 510(k) clearance for the NOVAREX. This device is classified as a Alloy, Metal, Base (Class II - Special Controls, product code EJH).
Submitted by Jeneric Ind. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1982, 22 days after receiving the submission on October 12, 1982.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3710.
| 510(k) Number | K823008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 1982 |
| Decision Date | November 03, 1982 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EJH — Alloy, Metal, Base |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3710 |