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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 Dr.
Raynham,  MA  02767
Applicant Contact BRIAN KANERVIKO
Correspondent
Codman & Shurtleff, Inc.
325 Paramount Dr.
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
Predetermined Change
Control Plan Authorized		 No
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