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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, peritoneal, automatic delivery
510(k) Number K173718
Device Name Liberty Cycler Set
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 Number876.5630
Classification Product Code
FKX  
Date Received12/05/2017
Decision Date 05/01/2018
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
Recalls CDRH Recalls
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