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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name subsystem, water purification
510(k) Number K182367
Device Name DIASAFEplusUS
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 Number876.5665
Classification Product Code
FIP  
Date Received08/31/2018
Decision Date 01/10/2019
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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