FDA 510(k) Application Details - K952390

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K952390
Device Name Neurological Stereotaxic Instrument
Applicant BRAINLAB MED. COMPUTERSYSTEME GMBH
GRUBER STRABE 46C
85586 POING/MUNCHEN 85586 DE
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Contact STEFAN VILSMEIER
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 05/22/1995
Decision Date 02/02/1996
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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