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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 K033340
Device Name LEKSELL SURGIPLAN WITH IMAGEMERGE
Applicant
Elekta Instrument AB
Birger Jarlsgatan 53
P.O. Box 7593
Stockholm,  SE SE-103 93
Applicant Contact PETER LOWENDAHL
Correspondent
Elekta Instrument AB
Birger Jarlsgatan 53
P.O. Box 7593
Stockholm,  SE SE-103 93
Correspondent Contact PETER LOWENDAHL
Regulation Number882.4560
Classification Product Code
HAW  
Date Received10/17/2003
Decision Date 02/12/2004
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
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