K-number	K181897
Device name	Reprocessed Marinr Diagnostic EP Catheter
Applicant	Innovative Health, LLC
Product code	NLH
Device class	Class II
Decision date	Nov 15, 2018
Decision	Substantially Equivalent
Regulation	870.1220

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Source

View the full FDA submission: accessdata.fda.gov

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Reprocessed Marinr Diagnostic EP Catheter

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