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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, for peritoneal dialysis, disposable
510(k) Number K173363
Device Name Cycler Drain Bag 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
KDJ  
Date Received10/26/2017
Decision Date 01/24/2018
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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