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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, radiation therapy, charged-particle, medical
510(k) Number K112981
Model 1041
Device Name SUN 125C IONIZATION CHAMBER
Original Applicant
SUN NUCLEAR CORP.
425 pineda court
melbourne,  FL  32940
Original Contact noel downey
Regulation Number892.5050
Classification Product Code
LHN  
Date Received10/06/2011
Decision Date 01/25/2012
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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