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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 K172022
Device Name CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
Applicant
Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham,  MA  02767
Applicant Contact Christopher Garete
Correspondent
Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham,  MA  02767
Correspondent Contact Christopher Garete
Regulation Number882.5550
Classification Product Code
JXG  
Date Received07/05/2017
Decision Date 10/03/2017
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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