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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 K103192
Device Name NAVIGATION MARKER, REFLECTIVE MARKER SPHERES
Applicant
Ilumark GmbH
Griesweg 47
Muhlheim,  DE 78570
Applicant Contact ANDRE WEINGERL
Correspondent
Ilumark GmbH
Griesweg 47
Muhlheim,  DE 78570
Correspondent Contact ANDRE WEINGERL
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
OLO  
Date Received10/29/2010
Decision Date 02/07/2011
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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