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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 K112156
Device Name CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
Applicant
MEDOS INTERNATIONAL SARL
325 Paramount Drive
Raynham,  MA  02767
Applicant Contact JOCELYN RAPOSO
Correspondent
MEDOS INTERNATIONAL SARL
325 Paramount Drive
Raynham,  MA  02767
Correspondent Contact JOCELYN RAPOSO
Regulation Number882.5550
Classification Product Code
JXG  
Date Received07/27/2011
Decision Date 10/17/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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