FDA 510(k) Application Details - K151156

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K151156
Device Name Neurological Stereotaxic Instrument
Applicant FIAGON GMBH
NEUENDORFSTRASSE 23B
HENNIGSDORF 16761 DE
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Contact DIRK MUCHA
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 05/01/2015
Decision Date 04/01/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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