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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 K160440
Device Name Leksell Gamma Knife Icon
Applicant
Elekta Instrument AB
Kungstensgatan 18
Stockholm,  SE 10393
Applicant Contact Alf Laurell
Correspondent
Elekta Instrument AB
Kungstensgatan 18
Stockholm,  SE 10393
Correspondent Contact Alf Laurell
Regulation Number892.5750
Classification Product Code
IWB  
Date Received02/17/2016
Decision Date 04/20/2016
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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