Name: Predicase
Price: 199 USD

K-number	K202461
Device name	ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
Applicant	Smisson-Cartledge Biomedical, LLC
Product code	LGZ
Device class	Class II
Decision date	Aug 12, 2022
Decision	Substantially Equivalent
Regulation	880.5725

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Source

View the full FDA submission: accessdata.fda.gov

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ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System

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