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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name accelerator, linear, medical
510(k) Number K121284
Device Name CHABNER XRT GARMENTS
Original Applicant
BFFL CO. INC
600 new hampshire avenue nw
suite 500
washington,  DC  20037
Original Contact evan p phelps
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/30/2012
Decision Date 06/14/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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