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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 K041719
Device Name ONCENTRA-VISIR
Applicant
NUCLETRON CORP.
8671 ROBERT FULTON DRIVE
COLUMBIA,  MD  21046
Applicant Contact LISA DIMMICK
Correspondent
NUCLETRON CORP.
8671 ROBERT FULTON DRIVE
COLUMBIA,  MD  21046
Correspondent Contact LISA DIMMICK
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received06/24/2004
Decision Date 07/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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