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510(k) K160847

Rockwell Medical CitraPure Acid Concetrate by Rockwell Medical — Product Code KPO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2016
Date Received
March 28, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K221652 — NIKKICART (March 3, 2023)
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