FDA 510(k) Application Details - K062146

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K062146
Device Name Neurological Stereotaxic Instrument
Applicant PRAXIM S.A
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 07/27/2006
Decision Date 08/21/2006
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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