INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000

Injector, Fluid, Non-electrically Powered

EQUIDYNE SYSTEMS, INC.

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.

Pre-market Notification Details

Device IDK022502
510k NumberK022502
Device Name:INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000
ClassificationInjector, Fluid, Non-electrically Powered
Applicant EQUIDYNE SYSTEMS, INC. 11770 BERNARDO PLAZA CT. SUITE 351 San Diego,  CA  92128
ContactJim Barely
CorrespondentJim Barely
EQUIDYNE SYSTEMS, INC. 11770 BERNARDO PLAZA CT. SUITE 351 San Diego,  CA  92128
Product CodeKZE  
CFR Regulation Number880.5430 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-29
Decision Date2002-09-05
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.