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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 K152558
Device Name Leksell Stereotactic System, Injection/ Aspiration Needle Kit
Applicant
ELEKTA INSTRUMENT AB
KUNGSTENSGATAN 18, P.O. BOX 7593
STOCKHOLM,  SE SE-103 93
Applicant Contact EMMA WIDMARK
Correspondent
ELEKTA INSTRUMENT AB
KUNGSTENSGATAN 18, P.O. BOX 7593
STOCKHOLM,  SE SE-103 93
Correspondent Contact EMMA WIDMARK
Regulation Number882.4560
Classification Product Code
HAW  
Date Received09/09/2015
Decision Date 03/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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