3M Comply Hydrogen Peroxide Indicator Tape

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 Indicator Tape.

Pre-market Notification Details

Device IDK183209
510k NumberK183209
Device Name:3M Comply Hydrogen Peroxide Indicator Tape
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant 3M Company 3M Center, Building 275-5W-06 St. Paul,  MN  55144
ContactNadia Battah
CorrespondentNadia Battah
3M Company 3M Center, Building 275-5W-06 St. Paul,  MN  55144
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-19
Decision Date2019-02-15
Summary:summary

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