3MTM AttestTM Mini Auto-reader 490M

Indicator, Biological Sterilization Process

3M

The following data is part of a premarket notification filed by 3m with the FDA for 3mtm Attesttm Mini Auto-reader 490m.

Pre-market Notification Details

Device IDK200092
510k NumberK200092
Device Name:3MTM AttestTM Mini Auto-reader 490M
ClassificationIndicator, Biological Sterilization Process
Applicant 3M 2510 Conway Ave, Bldg 275-5W-06 St. Paul,  MN  55144 -1000
ContactAndrew Wingen
CorrespondentAndrew Wingen
3M 2510 Conway Ave, 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 Received2020-01-16
Decision Date2020-04-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50707387790702 K200092 000

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