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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 K151156
Device Name Fiagon Navigation System
Applicant
Fiagon GmbH
Neuendorfstrasse 23b
Hennigsdorf,  DE 16761
Applicant Contact DIRK MUCHA
Correspondent
Fiagon GmbH
Neuendorfstrasse 23b
Hennigsdorf,  DE 16761
Correspondent Contact DIRK MUCHA
Regulation Number882.4560
Classification Product Code
HAW  
Date Received05/01/2015
Decision Date 04/01/2016
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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