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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 K172006
Device Name Alivio Ventricular Catheter and Flusher System (Alivio System)
Applicant
Alcyone Lifesciences. Inc.
250 Jackson Street Mill No. 5, Unit 494
Lowell,  MA  01852
Applicant Contact PJ Anand
Correspondent
Cyngus Regulatory
3753 Vineyard Place
Cincinnati,  OH  45226
Correspondent Contact Elsa Chi Abruzzo
Regulation Number882.5550
Classification Product Code
JXG  
Date Received07/03/2017
Decision Date 11/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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