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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Monitoring, Intracranial Pressure
510(k) Number K022553
Device Name CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L
Applicant
Integra Neurosciences
5955 Pacific Center Blvd.
San Diego,  CA  92121
Applicant Contact NANCY A MATHEWSON
Correspondent
Integra Neurosciences
5955 Pacific Center Blvd.
San Diego,  CA  92121
Correspondent Contact NANCY A MATHEWSON
Regulation Number882.1620
Classification Product Code
GWM  
Date Received08/02/2002
Decision Date 08/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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