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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
Recalls CDRH Recalls
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