K-number	K162945
Device name	VERIFY ASSERT STEAM Process Challenge Device
Applicant	STERIS Corporation
Product code	OWP
Device class	Class II
Decision date	Apr 28, 2017
Decision	Substantially Equivalent
Regulation	880.2805

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Source

View the full FDA submission: accessdata.fda.gov

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VERIFY ASSERT STEAM Process Challenge Device

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