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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 K910853
Device Name GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET
Applicant
Cordis Corp.
14201 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact MARVIN SUSSMAN
Correspondent
Cordis Corp.
14201 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact MARVIN SUSSMAN
Regulation Number882.5550
Classification Product Code
JXG  
Date Received02/28/1991
Decision Date 04/24/1991
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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