K092943 is an FDA 510(k) clearance for the ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE. This device is classified as a Syringe, Cartridge (Class II - Special Controls, product code EJI).
Submitted by Arnold Tuber Industries (Hamburg, US). The FDA issued a Cleared decision on December 11, 2009, 78 days after receiving the submission on September 24, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6770.
| 510(k) Number | K092943 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2009 |
| Decision Date | December 11, 2009 |
| Days to Decision | 78 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 |