The following data is part of a premarket notification filed by Innovators, Inc. with the FDA for E-z Jector.
Device ID | K830042 |
510k Number | K830042 |
Device Name: | E-Z JECTOR |
Classification | Syringe, Cartridge |
Applicant | INNOVATORS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EJI |
CFR Regulation Number | 872.6770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-07 |
Decision Date | 1983-01-26 |