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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 K231534
Device Name 5008X Hemodialysis System
Applicant
Fresenius Medical Care
920 Winter Street
Waltham,  MA  02451
Applicant Contact Denise M Oppermann
Correspondent
Fresenius Medical Care
920 Winter Street
Waltham,  MA  02451
Correspondent Contact Denise M Oppermann
Regulation Number876.5860
Classification Product Code
KDI  
Subsequent Product Codes
FIP   FJK   NII  
Date Received05/30/2023
Decision Date 02/02/2024
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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