FDA 510(k) Application Details - K051599

Device Classification Name Device, Monitoring, Intracranial Pressure

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510(K) Number K051599
Device Name Device, Monitoring, Intracranial Pressure
Applicant NEURORECOVERY, INC.
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
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Contact ROSINA ROBINSON
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Regulation Number 882.1620

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Classification Product Code GWM
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Date Received 06/16/2005
Decision Date 07/19/2005
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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