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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasound, Infusion, System
510(k) Number K051225
Device Name EKOS MICRO-INFUSION SYSTEM
Applicant
Ekos Corp.
22030 20th Ave. SE
Suite 101
Bothell,  WA  98021
Applicant Contact JOCELYN KERSTEN
Correspondent
Ekos Corp.
22030 20th Ave. SE
Suite 101
Bothell,  WA  98021
Correspondent Contact JOCELYN KERSTEN
Regulation Number870.1200
Classification Product Code
NUI  
Date Received05/12/2005
Decision Date 06/10/2005
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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