The following data is part of a premarket notification filed by Equidyne Systems, Inc. with the FDA for Injex 50 System.
| Device ID | K003864 |
| 510k Number | K003864 |
| Device Name: | INJEX 50 SYSTEM |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | EQUIDYNE SYSTEMS, INC. 11770 BERNARDO PLAZA CT. SUITE 351 San Diego, CA 92128 |
| Contact | Jim Barley |
| Correspondent | Jim Barley EQUIDYNE SYSTEMS, INC. 11770 BERNARDO PLAZA CT. SUITE 351 San Diego, CA 92128 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-13 |
| Decision Date | 2001-03-06 |