3M Attest Rapid Readout Biological Indicator

Indicator, Biological Sterilization Process

3M COMPANY

The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Attest Rapid Readout Biological Indicator.

Pre-market Notification Details

Device IDK160546
510k NumberK160546
Device Name:3M Attest Rapid Readout Biological Indicator
ClassificationIndicator, Biological Sterilization Process
Applicant 3M COMPANY 3M CENTER, BUILDING 275-5W-06 St. Paul,  MN  55144
ContactMatt Mortensen
CorrespondentMatt Mortensen
3M COMPANY 3M CENTER, BUILDING 275-5W-06 St. Paul,  MN  55144
Product CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-26
Decision Date2016-06-09
Summary:summary

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