FDA 510(k) Application Details - K063408

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K063408
Device Name Neurological Stereotaxic Instrument
Applicant PRAXIM MEDIVISION, SA
LE GRAND SABLON
4 AVENUE DE L'OBIOU
LA TRONCHE 38700 FR
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Contact MADY BATAILH
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 11/13/2006
Decision Date 02/28/2007
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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