Class Class II

NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) (K253462)

K253462 2026-01-29 Traditional
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Description

NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) by Fresenius Medical Care Renal Therapies Group, LLC, an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK253462
Clearance Date2026-01-29
Clearance TypeTraditional
Product CodeKPO
Regulation Number876.5820

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