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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K172238
Device Name CAREline Airless Hemodialysis Blood Tubing Sets
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St.
Waltham,  MA  02451
Applicant Contact Denise Oppermann
Correspondent
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St.
Waltham,  MA  02451
Correspondent Contact Denise Oppermann
Regulation Number876.5820
Classification Product Code
KOC  
Subsequent Product Code
FJK  
Date Received07/26/2017
Decision Date 12/14/2017
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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