Rockwell Medical Supply, LLC. Bicarbonate Solution Concentrates for Bicarbonate Dialysis

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K971053 ↗

FDA Product Code

KPO

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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