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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 K120668
Device Name SENTINEL
Original Applicant
C-RAD POSITIONING AB
bredgrand 18
uppsala,  SE 75320
Original Contact janina ostling
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/05/2012
Decision Date 07/30/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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