K-number	DEN110002
Device name	SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT
Applicant	STERIS Corporation
Product code	OVY
Device class	Class II
Decision date	Mar 30, 2012
Decision	Not Substantially Equivalent
Regulation	880.6887

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View the full FDA submission: accessdata.fda.gov

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SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT

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