The following data is part of a premarket notification filed by North, Inc. with the FDA for Easi-jector Control System.
| Device ID | K954189 |
| 510k Number | K954189 |
| Device Name: | EASI-JECTOR CONTROL SYSTEM |
| Classification | Syringe, Piston |
| Applicant | NORTH, INC. 303 WASHINGTON, SUITE B Northfield, MN 55057 |
| Contact | Jim Pokorney |
| Correspondent | Jim Pokorney NORTH, INC. 303 WASHINGTON, SUITE B Northfield, MN 55057 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-06 |
| Decision Date | 1995-10-19 |