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 |