K040671 is an FDA 510(k) clearance for the EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES. This device is classified as a Syringe, Cartridge (Class II - Special Controls, product code EJI).
Submitted by Anthogyr (Sallanches, FR). The FDA issued a Cleared decision on December 14, 2004, 274 days after receiving the submission on March 15, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6770.
| 510(k) Number | K040671 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2004 |
| Decision Date | December 14, 2004 |
| Days to Decision | 274 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EJI - Syringe, Cartridge |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6770 |