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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
Predetermined Change
Control Plan Authorized		 No
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