3M™ High Fluid-Resistant Surgical Mask And 3M™ High Fluid-Resistant Procedure Mask

Mask, Surgical

3M Health Care

The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m™ High Fluid-resistant Surgical Mask And 3m™ High Fluid-resistant Procedure Mask.

Pre-market Notification Details

Device IDK191355
510k NumberK191355
Device Name:3M™ High Fluid-Resistant Surgical Mask And 3M™ High Fluid-Resistant Procedure Mask
ClassificationMask, Surgical
Applicant 3M Health Care 3M Center, 2510 Conway Ave., Building 275-5W-06 St. Paul,  MN  55144
ContactAngie Draper
CorrespondentAngie Draper
3M Health Care 3M Center, 2510 Conway Ave., Building 275-5W-06 St. Paul,  MN  55144
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-21
Decision Date2019-09-11
Summary:summary

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