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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 K122451
Device Name EXACTRAC VERO
Original Applicant
BRAINLAB AG
kapellenstrasse 12
feldkirchen,  GM 85622
Original Contact alexander schwiersch
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/13/2012
Decision Date 09/28/2012
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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