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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 K103093
Device Name LEKSELL GAMMAPLAN
Applicant
Elekta Instrument AB
Kungstensgatan 18
P.O. Box 7593
Stockholm,  SE S-103 93
Applicant Contact BO NILSSON
Correspondent
Elekta Instrument AB
Kungstensgatan 18
P.O. Box 7593
Stockholm,  SE S-103 93
Correspondent Contact BO NILSSON
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received10/19/2010
Decision Date 12/21/2010
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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