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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, steerable
510(k) Number K050472
Device Name LYSUS INFUSION SYSTEM
Applicant
EKOS CORP.
22030 20TH AVENUE S.E.
SUITE 101
BOTHELL,  WA  98021
Applicant Contact JOCELYN KERSTEN
Correspondent
EKOS CORP.
22030 20TH AVENUE S.E.
SUITE 101
BOTHELL,  WA  98021
Correspondent Contact JOCELYN KERSTEN
Regulation Number870.1280
Classification Product Code
DRA  
Date Received02/24/2005
Decision Date 03/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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