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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 K191474
Device Name NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)
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
KPO  
Date Received06/04/2019
Decision Date 02/24/2020
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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