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FDA 510(k) Application Details - K193155
Device Classification Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
More FDA Info for this Device
510(K) Number
K193155
Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant
Nipro Renal Solutions USA, Corp.
509 Fishing Creek Road
Lewisberry, PA 17339 US
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Contact
Vincent DeGrandchamp
Other 510(k) Applications for this Contact
Regulation Number
876.5820
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Classification Product Code
KPO
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More FDA Info for this Product Code
Date Received
11/14/2019
Decision Date
11/25/2020
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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