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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
Applicant
BIOJECT MEDICAL TECHNOLOGIES INC.
7180 sw sandburg st ste 100
tigard,  OR  97223
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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