FDA 510(k) Application Details - K072379

Device Classification Name Device, Monitoring, Intracranial Pressure

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510(K) Number K072379
Device Name Device, Monitoring, Intracranial Pressure
Applicant INNERSPACE, INC.
1622 EDINGER AVENUE, SUITE C
TUSTIN, CA 92780 US
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Contact DON BOBO
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Regulation Number 882.1620

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Classification Product Code GWM
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Date Received 08/24/2007
Decision Date 04/29/2008
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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