INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000


Device Classification Name

injector, fluid, non-electrically powered

510(k) Number K022502
Device Name INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000
Original Applicant
EQUIDYNE SYSTEMS, INC.
11770 bernardo plaza ct.
suite 351
san diego, 
CA 
92128

Original Contact jim barely
Regulation Number 880.5430
Classification Product Code
KZE  
Date Received 07/29/2002
Decision Date 09/05/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No