Name: Predicase
Price: 199 USD

K-number	K201207
Device name	CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
Applicant	Fresenius Medical Care Renal Therapies Group, LLC
Product code	KOC
Device class	Class II
Decision date	Sep 18, 2020
Decision	Substantially Equivalent
Regulation	876.5820

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Source

View the full FDA submission: accessdata.fda.gov

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CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line

Everything you need for a 510(k) submission. Nothing you don't.