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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 K172035
Device Name EKOS ultrasound EVD Device, EVD Control Unit
Applicant
BTG International, Inc.
11911 North Creek Pkwy S
Bothell,  WA  98011
Applicant Contact Brit Baird
Correspondent
BTG International, Inc.
11911 North Creek Pkwy S
Bothell,  WA  98011
Correspondent Contact Jocelyn Kersten
Regulation Number882.5550
Classification Product Code
JXG  
Date Received07/05/2017
Decision Date 03/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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