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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 K132816
Device Name ONCENTRA BRACHY
Applicant
Nucletron B.V.
1917 29 3/4 Ave.
Rice Lake,  WI  54868
Applicant Contact LU ANNE JOHNSON
Correspondent
Nucletron B.V.
1917 29 3/4 Ave.
Rice Lake,  WI  54868
Correspondent Contact LU ANNE JOHNSON
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received09/09/2013
Decision Date 06/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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