FDA 510(k) Application Details - K072716

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K072716
Device Name Neurological Stereotaxic Instrument
Applicant BRAINLAB AG
KAPELLENSTRASSE 12
FELDKIRCHEN 85622 DE
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Contact BENJAMIN WAGNER
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 09/12/2007
Decision Date 10/12/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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