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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 K113276
Model SP-002
Device Name CATALYST
Applicant
C-RAD POSITIONING AB
bredgrand 18
uppsala, 
Contact janina ostling
Regulation Number892.5050
Classification Product Code
IYE  
Date Received11/07/2011
Decision Date 02/27/2012
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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