Name: Predicase
Price: 199 USD

K-number	K103331
Device name	VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES
Applicant	STERIS Corporation
Product code	JOJ
Device class	Class II
Decision date	Sep 1, 2011
Decision	Substantially Equivalent
Regulation	880.2800

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Source

View the full FDA submission: accessdata.fda.gov

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VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES

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