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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
Applicant
ELEKTA INSTRUMENT AB
KUNGSTENSGATAN 18
STOCKHOLM,  SE S-103 93
Applicant Contact VIVEKA WRETMAN
Correspondent
ELEKTA INSTRUMENT AB
KUNGSTENSGATAN 18
STOCKHOLM,  SE S-103 93
Correspondent 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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