FDA 510(k) Application Details - K050702

Device Classification Name Device, Monitoring, Intracranial Pressure

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510(K) Number K050702
Device Name Device, Monitoring, Intracranial Pressure
Applicant NEUROSYSTEMS LLC
103 POMFRET ROAD
WOODSTOCK, VT 05091-8029 US
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Contact JAMES R PETITE JR.
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Regulation Number 882.1620

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Classification Product Code GWM
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Date Received 03/18/2005
Decision Date 05/17/2005
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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