The following data is part of a premarket notification filed by Advanced Technology And Capital, Inc. with the FDA for Leeject 2 Dental Syringe And Needle System.
| Device ID | K171254 |
| 510k Number | K171254 |
| Device Name: | LeEject 2 Dental Syringe And Needle System |
| Classification | Syringe, Cartridge |
| Applicant | Advanced Technology And Capital, Inc. 5 Sylvan Ave. Englewood Cliffs, NJ 07632 |
| Contact | Alexander Lee |
| Correspondent | E.j. Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | EJI |
| CFR Regulation Number | 872.6770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-28 |
| Decision Date | 2017-11-16 |