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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 K854657
Device Name INTRACRANIAL PRESSURE MONITORING CUP CATHETERS
Applicant
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Applicant Contact DAVID KORNHAUSER
Correspondent
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Correspondent Contact DAVID KORNHAUSER
Regulation Number882.1620
Classification Product Code
GWM  
Date Received11/20/1985
Decision Date 12/27/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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