PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM


Device Classification Name

injector, fluid, non-electrically powered

510(k) Number K110456
Device Name PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
Applicant
PHARMAJET, INC.
400 cororate circle, suite n
golden, 
CO 
80401

Applicant Contact michael j ryan
Regulation Number 880.5430
Classification Product Code
KZE  
Date Received 02/16/2011
Decision Date 03/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No