FDA 510(k) Application Details - K020558

Device Classification Name Device, Monitoring, Intracranial Pressure

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510(K) Number K020558
Device Name Device, Monitoring, Intracranial Pressure
Applicant INTEGRA NEUROSCIENCES
5955 PACIFIC CENTER BLVD.
SAN DIEGO, CA 92121 US
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Contact NANCY MATHEWSON
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Regulation Number 882.1620

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Classification Product Code GWM
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Date Received 02/20/2002
Decision Date 03/21/2002
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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