K-number	K123811
Device name	STITCHKIT
Applicant	Origami Surgical, LLC
Product code	NBY
Device class	Class II
Decision date	Sep 5, 2013
Decision	Substantially Equivalent
Regulation	878.5035

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Source

View the full FDA submission: accessdata.fda.gov

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STITCHKIT

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