FDA 510(k) Application Details - K983410

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K983410
Device Name Neurological Stereotaxic Instrument
Applicant BRAINLAB, AG
3100 HANSEN WAY
PALO ALTO, CA 94304 US
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 09/28/1998
Decision Date 09/17/1999
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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