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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 K152152
Device Name Codman Certas Plus Programmable Valve
Applicant
Medos International Sarl
Chemin-Blanc 38
Le Locle,  CH CH-2400
Applicant Contact Jocelyn Raposo
Correspondent
Medos International Sarl
Chemin-Blanc 38
Le Locle,  CH CH-2400
Correspondent Contact Jocelyn Raposo
Regulation Number882.5550
Classification Product Code
JXG  
Date Received08/03/2015
Decision Date 10/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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