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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 K121270
Model B200
Device Name BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM
Original Applicant
BIOJECT MEDICAL TECHNOLOGIES INC.
7180 sw sandburg st ste 100
tigard,  OR  97223
Original Contact christine breitbach
Regulation Number880.5430
Classification Product Code
KZE  
Date Received04/26/2012
Decision Date 07/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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