INJEX 30 NEEDLE FREE INJECTION SYSTEM


Device Classification Name

injector, fluid, non-electrically powered

510(k) Number K022148
Device Name INJEX 30 NEEDLE FREE INJECTION SYSTEM
Original Applicant
EQUIDYNE SYSTEMS, INC.
11770 bernardo plaza ct.
suite 351
san diego, 
CA 
92128

Original Contact jim barley
Regulation Number 880.5430
Classification Product Code
KZE  
Date Received 07/02/2002
Decision Date 07/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No