K-number	K153679
Device name	Stryker Neptune E-SEP Smoke Evacuation Pencil
Applicant	Stryker Corporation
Product code	GEI
Device class	Class II
Decision date	Jan 22, 2016
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Stryker Neptune E-SEP Smoke Evacuation Pencil

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