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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 K120811
Device Name LEKSELL GAMMA KNIFE PERFEXION
Original Applicant
ELEKTA INSTRUMENT AB
kungstensgatan 18
stockholm,  SE s-103 93
Original Contact viveka wretman
Regulation Number892.5750
Classification Product Code
IWB  
Date Received03/16/2012
Decision Date 05/24/2012
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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