K-number	K161228
Device name	Radiance Ultra Series ZeroWire Embedded
Applicant	Nds Surgical Imaging, LLC
Product code	GCJ
Device class	Class II
Decision date	May 26, 2016
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Radiance Ultra Series ZeroWire Embedded

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