FDA 510(k) Application Details - K060336

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K060336
Device Name Neurological Stereotaxic Instrument
Applicant ORTHOSOFT, INC.
75 QUEEN ST., SUITE 3300
MONTREAL, QUEBEC H3C 2N6 CA
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Contact CHRISTOPHER MCLEAN
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 02/10/2006
Decision Date 04/28/2006
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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