3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 And 490H

Indicator, Biological Sterilization Process

3M Company

The following data is part of a premarket notification filed by 3m Company with the FDA for 3mtm Attesttm Super Rapid Steam Biological Indicator 1592, 3mtm Attesttm Super Rapid Steam Challenge Pack, 3mtm Attesttm Auto- Readers 490 And 490h.

Pre-market Notification Details

Device IDK192550
510k NumberK192550
Device Name:3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 And 490H
ClassificationIndicator, Biological Sterilization Process
Applicant 3M Company Bldg. 275-5W-06 St.paul,  MN  55144
ContactHilary B Hovde
CorrespondentHilary B Hovde
3M Company Bldg. 275-5W-06 St.paul,  MN  55144
Product CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-17
Decision Date2020-06-05

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