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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system,planning,radiation therapy treatment
510(k) Number K112723
Device Name EPLGRAY
Original Applicant
DOSLSOFT SA
1244 fairway valley court
lincoln,  CA  95648
Original Contact robert j morton
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received09/19/2011
Decision Date 02/08/2012
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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