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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 K162437
Device Name Codman EDS3 CSF External Drainage System
Applicant
Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Applicant Contact Christopher Garete
Correspondent
Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Correspondent Contact Christopher Garete
Regulation Number882.5550
Classification Product Code
JXG  
Date Received08/31/2016
Decision Date 10/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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