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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact MICHAEL J RYAN
Regulation Number880.5430
Classification Product Code
KZE  
Date Received06/02/2011
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
Predetermined Change
Control Plan Authorized		 No
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