Name: Predicase
Price: 199 USD

K-number	K191170
Device name	Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter
Applicant	Innovative Health, LLC
Product code	NLH
Device class	Class II
Decision date	Oct 30, 2019
Decision	Substantially Equivalent
Regulation	870.1220

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Source

View the full FDA submission: accessdata.fda.gov

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Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter

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