3M Attest Steam Chemical Integrator

Indicator, Physical/chemical 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.

Pre-market Notification Details

Device IDK193254
510k NumberK193254
Device Name:3M Attest Steam Chemical Integrator
ClassificationIndicator, Physical/chemical 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 CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-26
Decision Date2019-12-23
Summary:summary

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