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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dialysate concentrate for hemodialysis (liquid or powder)
510(k) Number K162716
Device Name bibag
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 Number876.5820
Classification Product Code
KPO  
Date Received09/29/2016
Decision Date 05/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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