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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name neurological stereotaxic instrument
510(k) Number K190887
Device Name Leksell Vantage Stereotactic System
Applicant
Elekta Instrument AB
Kungstensgatan 18
Stockholm,  SE 10393
Applicant Contact Helena Skar
Correspondent
Elekta Instrument AB
Kungstensgatan 18
Stockholm,  SE 10393
Correspondent Contact Alf Laurell
Regulation Number882.4560
Classification Product Code
HAW  
Date Received04/04/2019
Decision Date 08/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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