3M Attest Steam Chemical Integrator Test Pack

Indicator, Biological Sterilization Process

3M Company

The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Attest Steam Chemical Integrator Test Pack.

Pre-market Notification Details

Device IDK200766
510k NumberK200766
Device Name:3M Attest Steam Chemical Integrator Test Pack
ClassificationIndicator, Biological Sterilization Process
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 CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-25
Decision Date2020-07-02

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