The following data is part of a premarket notification filed by Equidyne Systems, Inc. with the FDA for Injex 30 Needle Free Injection System.
| Device ID | K022148 |
| 510k Number | K022148 |
| Device Name: | INJEX 30 NEEDLE FREE INJECTION 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-02 |
| Decision Date | 2002-07-23 |
| Summary: | summary |