Name: Predicase
Price: 199 USD

K-number	K192550
Device name	3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H
Applicant	3M Company
Product code	FRC
Device class	Class II
Decision date	Jun 5, 2020
Decision	Substantially Equivalent
Regulation	880.2800

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H

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