FDA 510(k) Application Details - K013930

Device Classification Name Device, Monitoring, Intracranial Pressure

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510(K) Number K013930
Device Name Device, Monitoring, Intracranial Pressure
Applicant NOVUS MONITORING LTD
ABBOTTS ANN, ANDOVER
HAMPSHIRE
UNITED KINGDOM SP11 7BH GB
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Contact PETER F GIBSON
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Regulation Number 882.1620

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Classification Product Code GWM
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Date Received 11/28/2001
Decision Date 02/20/2002
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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