Name: Predicase
Price: 199 USD

K-number	K192025
Device name	STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader
Applicant	Advanced Sterilization Products (Asp)
Product code	FRC
Device class	Class II
Decision date	Jan 23, 2020
Decision	Substantially Equivalent
Regulation	880.2800

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Source

View the full FDA submission: accessdata.fda.gov

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STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader

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