K-number	K170070
Device name	VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles
Applicant	STERIS Corporation
Product code	FRC
Device class	Class II
Decision date	Apr 28, 2017
Decision	Substantially Equivalent
Regulation	880.2800

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Source

View the full FDA submission: accessdata.fda.gov

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VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles

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