FDA 510(k) Application Details - K981846

Device Classification Name Device, Monitoring, Intracranial Pressure

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510(K) Number K981846
Device Name Device, Monitoring, Intracranial Pressure
Applicant CAMINO NEUROCARE, INC.
5955 PACIFIC CENTER BLVD.
SAN DIEGO, CA 92121 US
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Contact JODY J FLEMING
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Regulation Number 882.1620

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Classification Product Code GWM
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Date Received 05/26/1998
Decision Date 08/18/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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