Name: Predicase
Price: 199 USD

K-number	K190099
Device name	Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch
Applicant	Corinth Medtech, Inc.
Product code	FJL
Device class	Class II
Decision date	Mar 15, 2019
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch

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