3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

A Chemical Vapor Sterilization Multivariable Chemical Indicator

3M Health Care

The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m Attest Vaporized Hydrogen Peroxide Tri-metric Chemical Indicator 1348/1348e.

Pre-market Notification Details

Device IDK193110
510k NumberK193110
Device Name:3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
ClassificationA Chemical Vapor Sterilization Multivariable Chemical Indicator
Applicant 3M Health Care 2510 Conway Avenue, Bldg. 275-5W-06 St. Paul,  MN  55144 -1000
ContactAndrew Wingen
CorrespondentAndrew Wingen
3M Health Care 2510 Conway Avenue, Bldg. 275-5W-06 St. Paul,  MN  55144 -1000
Product CodeQKM  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-12
Decision Date2020-03-13

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