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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 K082221
Device Name RAYDOSE
Applicant
RAYSEARCH LABORATORIES AB
SVEAVAGEN 25, PLAN 9
STOCKHOLM,  SE SE-111 34
Applicant Contact ANDERS MURMAN
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 Received08/06/2008
Decision Date 10/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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