3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228

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(tm) Comply(tm) Hydrogen Peroxide Indicator Tape 1228.

Pre-market Notification Details

Device IDK212081
510k NumberK212081
Device Name:3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228
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 Received2021-07-02
Decision Date2021-09-05

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.