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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 K111558
Device Name SURGICASE GUIDE
Original Applicant
MATERIALISE N.V.
technologielaan 15
leuven,  BE 3001
Original Contact alexandra razzhivina
Regulation Number882.4560
Classification Product Code
HAW  
Date Received06/03/2011
Decision Date 03/27/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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