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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 K062922
Device Name MODIFICATION TO AQUADEX FLEXFLOW SYSTEM
Applicant
CHF SOLUTIONS, INC.
7601 NORTHLAND DR. STE. 170
BROOKLYN PARK,  MN  55428
Applicant Contact CHRIS SCAVOTTO
Correspondent
CHF SOLUTIONS, INC.
7601 NORTHLAND DR. STE. 170
BROOKLYN PARK,  MN  55428
Correspondent Contact CHRIS SCAVOTTO
Regulation Number876.5860
Classification Product Code
KDI  
Date Received09/28/2006
Decision Date 12/13/2006
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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