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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Radionuclide
510(k) Number K063512
Device Name LEKSELL GAMMA KNIFE PERFEXION
Applicant
Elekta Instrument AB
Kungstensgatan 18, P.O. Box 7593
Stockholm,  SE SE-103 93
Applicant Contact ANDERS SKOGLUND
Correspondent
Elekta Instrument AB
Kungstensgatan 18, P.O. Box 7593
Stockholm,  SE SE-103 93
Correspondent Contact ANDERS SKOGLUND
Regulation Number892.5750
Classification Product Code
IWB  
Date Received11/20/2006
Decision Date 03/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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