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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 K040979
Device Name ELEKTA MICRODRIVE, MODEL 916716
Applicant
ELEKTA INSTRUMENT AB
KUNGSTENSGATAN 18
PO BOX 7593
STOCKHOLM,  SE S-103 93
Applicant Contact ANDERS SKOGLUND
Correspondent
ELEKTA INSTRUMENT AB
KUNGSTENSGATAN 18
PO BOX 7593
STOCKHOLM,  SE S-103 93
Correspondent Contact ANDERS SKOGLUND
Regulation Number882.4560
Classification Product Code
HAW  
Date Received04/15/2004
Decision Date 07/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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