3M Comply Hydrogen Peroxide Chemical Indicator

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 Comply Hydrogen Peroxide Chemical Indicator.

Pre-market Notification Details

Device IDK192937
501k NumberK192937
Device Name:3M Comply Hydrogen Peroxide Chemical Indicator
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)
Regulation Medical SpecialtyGeneral Hospital
501k Review PanelGeneral Hospital
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-18
Decision Date2019-11-16

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