Name: Predicase
Price: 199 USD

K-number	K191474
Device name	NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)
Applicant	Fresenius Medical Care Renal Therapies Group, LLC
Product code	KPO
Device class	Class II
Decision date	Feb 24, 2020
Decision	Substantially Equivalent
Regulation	876.5820

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Source

View the full FDA submission: accessdata.fda.gov

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NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)

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