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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 K053350
Device Name MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS
Applicant
Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham,  MA  02767
Applicant Contact BRIAN KANERVIKO
Correspondent
Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham,  MA  02767
Correspondent Contact BRIAN KANERVIKO
Regulation Number882.5550
Classification Product Code
JXG  
Date Received12/02/2005
Decision Date 01/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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