PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI


Device Classification Name

injector, fluid, non-electrically powered

510(k) Number K111517
Device Name PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
Applicant
PHARMAJET, INC.
400 cororate circle, suite n
golden, 
CO 
80401

Applicant Contact michael j ryan
Correspondent
PHARMAJET, INC.
400 cororate circle, suite n
golden, 
CO 
80401

Correspodent Contact michael j ryan
Regulation Number 880.5430
Classification Product Code
KZE  
Date Received 06/02/2011
Decision Date 07/27/2011
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