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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 K023874
Device Name SYSTEM 100 ULTRAFILTRATION CATHETER
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  
Subsequent Product Code
MPB  
Date Received11/21/2002
Decision Date 11/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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