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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 K993766
Device Name HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM
Applicant
HELAX AB
447 MARCH ROAD
KANATA ONTARIO,  CA K2K 1X8
Applicant Contact E.S. MARTELL
Correspondent
HELAX AB
447 MARCH ROAD
KANATA ONTARIO,  CA K2K 1X8
Correspondent Contact E.S. MARTELL
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received11/08/1999
Decision Date 12/08/1999
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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