K-number	K162321
Device name	EasyClip Xpress
Applicant	Restore Surgical, LLC Dba Instratek
Product code	JDR
Device class	Class II
Decision date	Feb 10, 2017
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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EasyClip Xpress

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