3M Attest Super Rapid 5 Steam-Plus Challenge Pack

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 Super Rapid 5 Steam-plus Challenge Pack.

Pre-market Notification Details

Device IDK193154
510k NumberK193154
Device Name:3M Attest Super Rapid 5 Steam-Plus Challenge Pack
ClassificationIndicator, Biological Sterilization Process
Applicant 3M Company Bldg. 275-5W-06 St. Paul,  MS  55144
ContactMary Fretland
CorrespondentMary Fretland
3M Company Bldg. 275-5W-06 St. Paul,  MS  55144
Product CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-14
Decision Date2020-02-07

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