K-number	K190341
Device name	iC-GN iC-Cassette for use on the iC-System
Applicant	Icubate, Inc.
Product code	PEN
Device class	Class II
Decision date	Jun 28, 2019
Decision	Substantially Equivalent
Regulation	866.3365

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View the full FDA submission: accessdata.fda.gov

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iC-GN iC-Cassette for use on the iC-System

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