The following data is part of a premarket notification filed by Equidyne Systems, Inc. with the FDA for Injex 30 Needle Free Injection System, Model 100000.
Device ID | K022502 |
510k Number | K022502 |
Device Name: | INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000 |
Classification | Injector, Fluid, Non-electrically Powered |
Applicant | EQUIDYNE SYSTEMS, INC. 11770 BERNARDO PLAZA CT. SUITE 351 San Diego, CA 92128 |
Contact | Jim Barely |
Correspondent | Jim Barely 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 | 2002-07-29 |
Decision Date | 2002-09-05 |
Summary: | summary |