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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 K081281
Device Name OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)
Applicant
Nucletron Corporation
8671 Robert Fulton Dr.
Columbia,  MD  21046 -2133
Applicant Contact LISA DIMMICK
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received05/06/2008
Decision Date 05/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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