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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 K061540
Device Name LEKSELL GAMMAPLAN
Applicant
Elekta Instrument AB
Kungstensgatan 18
P.O. Box 7593
Stockholm,  SE S-103 93
Applicant Contact LOUISE LINGBLAD
Correspondent
Elekta Instrument AB
Kungstensgatan 18
P.O. Box 7593
Stockholm,  SE S-103 93
Correspondent Contact LOUISE LINGBLAD
Regulation Number892.5750
Classification Product Code
IWB  
Date Received06/05/2006
Decision Date 07/05/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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