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FDA 510(k) Application Details - K191474
Device Classification Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
More FDA Info for this Device
510(K) Number
K191474
Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter Street
Waltham, MA 02451 US
Other 510(k) Applications for this Company
Contact
Denise Oppermann
Other 510(k) Applications for this Contact
Regulation Number
876.5820
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Classification Product Code
KPO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/04/2019
Decision Date
02/24/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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