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510(k) K172006

Alivio Ventricular Catheter and Flusher System (Alivio System) by Alcyone Lifesciences, Inc. — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2017
Date Received
July 3, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

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