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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 K080355
Device Name LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
Applicant
ELEKTA INSTRUMENT AB
KUNGSTENSGATAN 18
P.O.BOX 7593
STOCKHOLM,  SE S-103 93
Applicant Contact PETER LOWENDAHL
Correspondent
ELEKTA INSTRUMENT AB
KUNGSTENSGATAN 18
P.O.BOX 7593
STOCKHOLM,  SE S-103 93
Correspondent Contact PETER LOWENDAHL
Regulation Number882.4560
Classification Product Code
HAW  
Date Received02/11/2008
Decision Date 05/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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