FDA 510(k) Application Details - K020780

Device Classification Name Device, Monitoring, Intracranial Pressure

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510(K) Number K020780
Device Name Device, Monitoring, Intracranial Pressure
Applicant MEDEX, INC.
6250 SHIER RINGS RD.
DUBLIN, OH 43016 US
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Contact BARBARA LAW
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Regulation Number 882.1620

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Classification Product Code GWM
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Date Received 03/11/2002
Decision Date 05/20/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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