3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

A Chemical Vapor Sterilization Multivariable Chemical Indicator

3M Company

The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Attest Vaporized Hydrogen Peroxide Tri-metric Chemical Indicator 1348/1348e.

Pre-market Notification Details

Device IDK212022
510k NumberK212022
Device Name:3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
ClassificationA Chemical Vapor Sterilization Multivariable Chemical Indicator
Applicant 3M Company 3M Center, Building 275-5W-06 St. Paul,  MN  55144
ContactMary Fretland
CorrespondentMary Fretland
3M Company 3M Center, Building 275-5W-06 St. Paul,  MN  55144
Product CodeQKM  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-29
Decision Date2022-04-20

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