3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER

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 / 3m Attest Auto-reader.

Pre-market Notification Details

Device IDK140392
510k NumberK140392
Device Name:3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER
ClassificationIndicator, Biological Sterilization Process
Applicant 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul,  MN  55144 -1000
ContactSuzanne Leung
CorrespondentSuzanne Leung
3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul,  MN  55144 -1000
Product CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-14
Decision Date2014-08-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50707387769753 K140392 000

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