K830042 is an FDA 510(k) clearance for the E-Z JECTOR. This device is classified as a Syringe, Cartridge (Class II - Special Controls, product code EJI).
Submitted by Innovators, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1983, 19 days after receiving the submission on January 7, 1983.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6770.
| 510(k) Number | K830042 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 07, 1983 |
| Decision Date | January 26, 1983 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EJI — Syringe, Cartridge |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6770 |