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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 K233159
Device Name pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter Street
Waltham,  MA  02451
Applicant Contact Timothy Groves
Correspondent
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter Street
Waltham,  MA  02451
Correspondent Contact Timothy Groves
Regulation Number876.5820
Classification Product Code
KPO  
Date Received09/27/2023
Decision Date 12/01/2023
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
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