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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K855058
Device Name EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID
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 Number882.5550
Classification Product Code
JXG  
Date Received12/18/1985
Decision Date 01/10/1986
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
Recalls CDRH Recalls
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