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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dialysate concentrate for hemodialysis (liquid or powder)
510(k) Number K192209
Device Name Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter Street
Waltham,  MA  02451
Applicant Contact Denise Oppermann
Correspondent
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter Street
Waltham,  MA  02451
Correspondent Contact Denise Oppermann
Regulation Number876.5820
Classification Product Code
KPO  
Date Received08/14/2019
Decision Date 05/08/2020
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
Recalls CDRH Recalls
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