K-number	K203560
Device name	STERIZONE VP4 Test Pack
Applicant	Tso3 Inc., Now A Part of Stryker
Product code	FRC
Device class	Class II
Decision date	Mar 24, 2021
Decision	Substantially Equivalent
Regulation	880.2800

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Source

View the full FDA submission: accessdata.fda.gov

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STERIZONE VP4 Test Pack

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