FDA 510(k) Application Details - K092239

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K092239
Device Name Neurological Stereotaxic Instrument
Applicant MEDTECH S.A.
1006 RUE DE LA CROIX VERTE
PARC EUROMEDICINE (BAT 8)
MONTPELLIER 34090 FR
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Contact BERTIN NAHUM
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 07/23/2009
Decision Date 11/17/2009
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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