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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
Predetermined Change
Control Plan Authorized		 No
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