K-number	K161769
Device name	Reprocessed Supreme Diagnostic Electrophysiology Catheters
Applicant	Innovative Health, LLC
Product code	DRF
Device class	Class II
Decision date	Dec 6, 2016
Decision	Substantially Equivalent
Regulation	870.1220

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Source

View the full FDA submission: accessdata.fda.gov

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Reprocessed Supreme Diagnostic Electrophysiology Catheters

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