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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 EAST AURORA ROAD
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
Recalls CDRH Recalls
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