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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 K103515
Device Name EQUAL DOSE
Applicant
NUCLETRON CORPORATION
7021 COLUMBIA GATEWAY DR.
SUITE 200
COLUMBIA,  MD  21046 -2133
Applicant Contact MANAL YOUSOF
Correspondent
NUCLETRON CORPORATION
7021 COLUMBIA GATEWAY DR.
SUITE 200
COLUMBIA,  MD  21046 -2133
Correspondent Contact MANAL YOUSOF
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received11/30/2010
Decision Date 09/15/2011
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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