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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
Recalls CDRH Recalls
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