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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dialyzer, high permeability with or without sealed dialysate system
510(k) Number K040489
Device Name AQUADEX SYSTEM 100, MODEL A1100
Applicant
CHF SOLUTIONS, INC.
SUITE 170-7601 NORTHLAND DR.
BROOKLYN PARK,  MN  55428
Applicant Contact AMY PETERSON
Correspondent
CHF SOLUTIONS, INC.
SUITE 170-7601 NORTHLAND DR.
BROOKLYN PARK,  MN  55428
Correspondent Contact AMY PETERSON
Regulation Number876.5860
Classification Product Code
KDI  
Date Received02/26/2004
Decision Date 04/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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