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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 K242053
Device Name FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St.
Waltham,  MA  02451
Applicant Contact Timothy Groves
Correspondent
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St.
Waltham,  MA  02451
Correspondent Contact Timothy Groves
Regulation Number876.5860
Classification Product Code
KDI  
Date Received07/12/2024
Decision Date 03/21/2025
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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