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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 K023224
Device Name INFUSION CATHETER EXTENSION SET
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 Received09/27/2002
Decision Date 10/25/2002
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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