FDA 510(k) Application Details - K040235

Device Classification Name Device, Monitoring, Intracranial Pressure

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510(K) Number K040235
Device Name Device, Monitoring, Intracranial Pressure
Applicant INTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536 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 02/02/2004
Decision Date 04/20/2004
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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