FDA 510(k) Application Details - K992916

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K992916
Device Name Neurological Stereotaxic Instrument
Applicant BRAINLAB
100 MARINE PKWY.
SUITE 305
REDWOOD CITY, CA 94065 US
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Contact ERIC LINDQUIST
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 08/30/1999
Decision Date 01/11/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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