3M Comply Hydrogen Peroxide Chemical Indicator 1248

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 1248.

Pre-market Notification Details

Device IDK150622
510k NumberK150622
Device Name:3M Comply Hydrogen Peroxide Chemical Indicator 1248
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant 3M Company 3M Center, Building 275-5W-06 St.paul,  MN  55144
ContactHilary B. Hovde
CorrespondentHilary B. Hovde
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 Received2015-03-11
Decision Date2015-09-29
Summary:summary

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