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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 K031980
Device Name MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM
Applicant
ELEKTA INSTRUMENT AB
BIRGER JARLSGATAN 53
PO BOX 7593
STOCKHOLM,  SE SE-103 93
Applicant Contact PETER LOWENDAHL
Correspondent
ELEKTA INSTRUMENT AB
BIRGER JARLSGATAN 53
PO BOX 7593
STOCKHOLM,  SE SE-103 93
Correspondent Contact PETER LOWENDAHL
Regulation Number882.4560
Classification Product Code
HAW  
Date Received06/26/2003
Decision Date 07/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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